Mouth and Tooth Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Periodontal Diseases

Keratosis, Actinic

Keratosis

Lichen Planus

Mouth Diseases

Leukoplakia

Skin Diseases

Precancerous Conditions

Stomatognathic Diseases

Lichenoid Eruptions

Exanthema

Skin Diseases, Papulosquamous

Pathological Conditions, Anatomical

All Drugs and Chemicals

Nicotine

Tobacco cessation intervention is implemented for 12 weeks. The nicotine dependence status is evaluated by the FTND (Fagerstrom Test for Nicotine Dependence) test. The point 3 or more is regarded as a moderate or high tobacco dependence and determining a cessation intervention. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Even if participants fail to abstain from smoking, the oral treatment is continued. In case of the use of the NRTs (nicotine patch and/or gum), the investigators supply it for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy.

Those who do not intention to abstinence from smoking strongly and/or having less than 3 points in FTND test are allocated to non-tobacco cessation intervention group. The same treatment as the tobacco cessation intervention group is carried out for their oral diseases.

The nicotine dependence status is evaluated by the Fagerstrom Test for Nicotine Dependence test; those who 3 or more score are eligible for the intervention.

During the study, attending doctors implement a tobacco cessation intervention with standard treatments for above oral diseases.

Even if the subjects failed to abstain from smoking, the treatment is continued.

In case of the use of the nicotine replacement therapy, The investigators supply NRTs (nicotine patch or gum) for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy.

Tobacco cessation intervention

Toru Nagao, PhD, DDS

Jinichi Fukuda, DDS, PhD

Jinichi Fukuda, PhD, DDS

This study is to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial. Tobacco cessation intervention is implemented for 12 weeks. During the tobacco cessation intervention for the subjects, attending doctors implement standard treatments for their oral diseases. Improvement of each disease is evaluated between smoking cessation intervention group and non-cessation intervention group.

It has been concluded that available evidence suggests that behavioral interventions for tobacco cessation conducted by oral health professionals incorporating an oral examination component in the dental office or community setting may increase tobacco abstinence rates among both cigarette smokers and smokeless tobacco users (Cochrane Database Syst Rev.6:CD005084.) However, efficacy of tobacco cessation for oral diseases by oral health professionals are not elucidated. There are few studies on tobacco cessation intervention by dentists but none in terms of reduction of oral diseases or further disease prevention. Association for the Japanese Academy of Maxillofacial Implants, Association for the Japanese Society of Oral and Maxillofacial Surgeons, Association for the Japanese Society of Oral Implantology, Japanese Society of Oral Medicine, Japanese Society of Periodontology, Japanese Academy of Clinical Periodontology, Japanese Society for Oral Health, Japanese Society of Dentistry for Medically Compromised Patient and Japanese Society of Oral Oncology conduct a study to verify the efficacy of tobacco cessation in patients with oral diseases; periodontitis, dental implant and oral mucosal diseases by a multicenter prospective trial.

Tobacco Cessation Intervention Study for Oral Diseases

Efficacy of Tobacco Cessation for Improving Oral Diseases - Multicenter Prospective Trial

Pocket depth and attachment loss with or without surgical treatment

Per-implant marginal bone loss by a standardized X-ray photo

Size reduction (major x minor axis /mm) at a predominant site for non-surgical group

Biochemical validation tests confirming for quit smoking is applied for all subjects. Measurements of expired carbon monoxide (CO) where the test is available are analyzed at each period. Otherwise cotinine levels of the saliva samples are analyzed by a semi-quantitative analysis by NicAlert™.

The oral mucosa tissues are collected by buccal swab.

Association for the Japanese Academy of Maxillofacial Implants

Director

Dental Caries

Head and Neck Neoplasms

Tooth Demineralization

Tooth Diseases

Curative intent radiotherapy for head and neck cancer. Doses will be prescribed by an independent Clinical Oncology team. There will be no alteration or experimentation of radiotherapy dosage

Radiotherapy (curative) for head and neck cancer

Ciaran E Moore, BDS (Hons)

Gerry McKenna, BDS

Gerry McKenna, PhD, BDS, FDS

Background Post-radiotherapy head and neck cancer (HANC) patients are at increased risk of dental caries and periodontal disease due to radiation-related damage to the teeth and salivary glands. Currently the exact aetiology of post-radiotherapy dental disease, and variation in its incidence and severity based on tumour location and radiotherapy dose, is poorly understood. Consequently there is a lack of clear guidance on how HANC patients should be dentally managed both before and after their radiotherapy.

Aim The aim of this study is to quantify the relationship between dental radiation dose, 'spared' parotid gland radiation dose, tumour location, and post-radiotherapy dental disease.

Methods A prospective cohort study will be undertaken in HANC patients treated with radiotherapy. A total of 215 patients will be recruited over a period of 2.5 years. Participants will be assessed and rendered dentally fit prior to radiotherapy in the School of Dentistry, Belfast. All patients will be followed-up at 6, 12, and 24-months post-radiotherapy. Data to be collected at each visit will include: total number of carious teeth, periodontal disease indices, salivary flow rates, diet, oral hygiene, mouth opening, xerostomia and oral health-related quality of life.

Radiotherapy, including individual tissue-dose exposures, will be prescribed by the Clinical Oncology team as per current practice. Doses to the teeth and 'spared' parotid gland will be determined using radiotherapy research software (Non-Clinical Eclipse System sold by Varian Medical Systems UK Ltd).

Using appropriate statistical tests, data analysis will determine the relationship between dental disease, radiation dose, and tumour location.

Anticipated variation in the incidence and severity of post-radiotherapy dental disease based on the radiotherapy dose and tumour location, will inform the development of a clinical risk-assessment tool that will allow dentists to categorise patients as 'high' or 'low' risk of future disease. Guidelines regarding pre-radiotherapy dental extractions and post-radiotherapy preventative strategies will also be developed and will advise clinicians based on this risk assessment.

A micro-costings study will be undertaken to evaluate patient and healthcare costs associated with the diagnosis and management of pre- and post-radiotherapy dental disease.

Plan of investigation

Clinical hypothesis The primary hypothesis of the study is that increased mean radiation dose to the teeth and to the 'spared' parotid gland is associated with an increase in the mean number of carious teeth and in the proportion with periodontal disease 2 years post-radiotherapy.

Study design: Prospective cohort study.

* Pre-radiotherapy assessment at baseline and patients rendered dentally fit.
* Post-radiotherapy follow-up assessments at 6 months, 12 months, and 24 months.

Pre-radiotherapy assessment:

In line with current practice, the Multidisciplinary Head and Neck Cancer Team (Royal Victoria Hospital, Belfast) will continue to refer head and neck cancer patients for pre-radiotherapy dental assessment to the School of Dentistry, Belfast. Referred patients will be assessed in the existing 'Head and Neck Clinic' in the School of Dentistry. All potentially eligible patients will be informed of the research study and invited to participate. Each recruited patient will be assessed by a trained and calibrated dentist (examiner). Examiners will undergo pre-study training and calibration to ensure consistent clinical measurements. Inter-examiner consistency will be calculated using the Kappa statistic. A structured protocol will be followed. Radiographs may be requested provided specific criteria have been fulfilled. The same examiner(s) will interpret and record data from all radiographs.

The following measurements will be collected:

* Dental caries: The presence or absence of dental caries on each tooth will be determined using the World Health Organization's criteria and coding system and ICDAS-II, and recorded in a modified version of the Oral Health Assessment Form for Adults, 2013. Radiographic evidence of secondary caries or caries into dentine will also be recorded.
* Periodontal disease: A six-point periodontal charting will be performed for all patients. Clinical attachment loss and probing pocket depths will be measured using a Williams Periodontal Probe and recorded for six sites on each tooth. The 'Centers for Disease Control and Prevention (CDC)', in partnership with the 'American Academy of Periodontology (AAP)' workgroup definition of periodontitis will be used to identify those with active periodontal disease: 2 or more interproximal sites with attachment loss ≥3 mm, and 2 or more interproximal sites with pocket depths ≥4 mm (not on same tooth) or one site with pocket depth ≥5 mm.
* Stimulated salivary flow rate using paraffin pellets.
* Ruler measurement of mouth opening.
* Oral hygiene practice and dietary assessment using the World Health Organization's Oral Health Questionnaire for Adults.
* Subjective assessment of quality of life and experience of xerostomia using questionnaire booklets containing the European Organization for Research and Treatment of Cancer (EORTC) QLQC30 quality-of-life instrument, the associated head and neck specific module HN35, the Oral Health Impact Profile, and the modified Xerostomia Questionnaire.

All patients will receive standardised oral hygiene and dietary advice. A dental treatment plan will be formulated for each patient to ensure adequate dental fitness prior to radiotherapy. Dental treatment required pre-radiotherapy (e.g. restorations and extractions) will be co-ordinated by the School of Dentistry in line with current practice.

Post-radiotherapy assessments:

Participants will be followed-up at 6 months, 12 months, and 24 months post-radiotherapy.

At each follow-up visit, patients will undergo dental assessment in the School of Dentistry, Belfast. The following measurements will be collected (using the same methods and examiners outlined above): charting of dental caries, 6-point clinical attachment loss and probing pocket depth charting, stimulated salivary flow rate, mouth opening, oral hygiene practice, dietary assessment, quality of life, and xerostomia. A structured protocol will be followed. Radiographs may be requested provided specific criteria have been fulfilled. At each visit, patients will receive standardised oral hygiene and dietary advice. Consultants will oversee treatment plans for the restoration of dental health. Required treatment will be co-ordinated by the School of Dentistry in line with current practice.

Radiation dose and tumour location determination Patients will receive radiotherapy as prescribed by their Consultant Clinical Oncologist. The Clinical Oncologist will also plan individual tissue exposures in line with current practice. Using additional research software, doses to the teeth and to the 'spared' parotid gland will be calculated after the teeth and parotid glands have been contoured on each patient's radiotherapy planning CT scan. The Clinical Oncologist will contour the parotid glands in line with current practice. A dentist will contour the teeth on patient-anonymised CT scans. Tumour location will be determined from the initial referral letter sent by the Head and Neck Cancer Multidisciplinary Team.

Sample size Simplified sample size calculations were conducted based upon an independent samples t-test and correlation coefficient. Assuming the standard deviation of the number of carious teeth in post-radiotherapy head and neck cancer patients is 4.0 (based upon the results of a 10-year School of Dentistry audit) and comparing patients receiving over 20 Gray to the 'spared' parotid gland with those receiving under 20 Gray (based upon a 80%/20% distribution seen in a Cancer Centre radiation dose audit), the investigators would require a total sample of 150 patients with available data to have over 80% power to detect a difference of 3.0 in the mean number of carious teeth between the under 20 Gy and over 20 Gy groups as statistically significant at the 5% level. Furthermore, a sample size of 150 patients would allow 80% power to detect, as significant at the 5% level, a correlation coefficient of 0.22 for the association between radiation dose to the 'spared' parotid gland (Gy) and the number of carious teeth. Assuming 30% dropout the investigators would therefore need to recruit 215 patients.

Statistical analysis Primary outcome measures to be analysed include: (1) the number of carious teeth and (2) the presence of periodontal disease.

1. Initial comparisons between the radiation dose to the 'spared' parotid gland and the number of carious teeth will be performed using independent t-tests (categorising radiation dose as \<20Gy and \>20Gy) and ANOVA (categorising radiation dose as \<20Gy, 20-30Gy, 30-40Gy, and \>40Gy) as appropriate. Adjusted analysis will be performed using multiple linear regression, with the number of carious teeth as the outcome variable, radiation dose to the 'spared' parotid gland as an explanatory variable (categorised as above) along with potential confounding variables: dental radiation dose, oral hygiene practice, diet, and mouth opening. Without categorising radiation dose, a separate analysis will be conducted using linear regression with the number of carious teeth as the outcome variable and radiation dose to the 'spared' parotid gland (Gy) as the explanatory variable to give the increase in the number of carious teeth per 10 unit increase in Gray. If the number of carious teeth is not normally distributed transformations will be used prior to analysis or equivalent non-parametric techniques will be used.
2. Initial comparisons of the association between radiation dose to the 'spared' parotid gland (categorised as above) and the presence of periodontal disease (Yes/No) will be performed using chi-square tests. Adjusted analysis will be performed using logistic regression with presence of periodontal disease as the outcome variable, radiation dose to the 'spared' parotid gland as the explanatory variable and dental radiation dose, oral hygiene practice, diet, smoking, medical history, and mouth opening as potential confounders. Similar analyses will be undertaken to determine the effects of dental radiation dose and tumour location on the number of carious teeth and the presence of periodontal disease in post-radiotherapy head and neck cancer patients.

Secondary outcomes to be analysed include: quality of life, salivary flow rate, diet, oral hygiene practice, mouth opening, xerostomia (all change from baseline); tooth loss, and denture wear. Dichotomous outcomes will be analysed using chi-square tests and logistic regression as above. Continuous outcomes will be analysed as above, apart from variables with baseline measurements, for which ANCOVA will be used to compare outcome measurements adjusting for baseline. Adjusted analyses will use multiple linear regression models as above but with baseline measurements as an additional explanatory variable.

A micro-costings study will also be undertaken to evaluate patient and healthcare costs in relation to the diagnosis and treatment of pre- and post-radiotherapy dental disease.

* Patient costs to be evaluated include: cost of travel to dental appointments, time off work to attend for dental treatment, cost of dental treatment incurred pre and post-radiotherapy (general or private practice), out-of-pocket expenses (e.g. pain-relief medications).
* Healthcare costs to be evaluated include: clinical and administration staff costs for pre- and post-radiotherapy dental assessments and treatment, equipment, general overheads, remuneration of primary care dental practitioners.

Cost savings due to improved treatment planning of patients will also be hypothesised.

Post-radiation Dental Disease Amongst Head and Neck Cancer Patients

The Effect of Dental and Salivary Gland Radiation Dose on the Occurrence of Post-radiotherapy Dental Disease in Patients With Head and Neck Cancer

The mean number of carious teeth amongst head and neck cancer patients post-radiotherapy

The proportion of head and neck cancer patients with periodontal disease post-radiotherapy.

Change from baseline. Range of scores from 0 (no xerostomia) to 90 (worst xerostomia)

Change from baseline. 14 oral health problems presented - patients asked to score how often they are personally encountered (very often, fairly often, occasionally, hardly ever, never, don't know)

Change from baseline. Respondents asked to detail how often they consume e.g. sugar buns

Change from baseline. Patients asked to indicate e.g. how often do you brush your teeth

Queen's University, Belfast

Belfast Health and Social Care Trust

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Infections

Immune System Diseases

Diabetes Mellitus

Gingivitis

Diabetes Mellitus, Type 1

Necrosis

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Autoimmune Diseases

Communicable Diseases

Gingival Diseases

Children with type 1 diabetes mellitus and gingivitis

Children with type 1 diabetes mellitus and healthy gingiva

Systemically healthy patients with gingivitis

Systemically healthy patients with healthy gingiva

ELISA

Sultan KELES, Dr.

This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and gingivitis.

Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years) will be recruited for the study. The children will be classified into four subgroups based on their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2) Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH, n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.

Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus

Gingival Crevicular Fluid Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus

Aydin Adnan Menderes University

Assist. Prof.Dr.

Heart and Blood Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Respiratory Tract (Lung and Bronchial) Diseases

Coronary Artery Disease

Vascular Diseases

Stroke

Chronic Disease

Obesity

Heart Diseases

Dementia

Coronary Disease

Myocardial Ischemia

Somatoform Disorders

Respiration Disorders

Respiratory Tract Diseases

Psychophysiologic Disorders

Ischemia

Arteriosclerosis

Arterial Occlusive Diseases

Chronic Graft Versus Host Disease

Annika Jagodzinski, MD

Tanja Zeller, Professor

Susannw Bruder

Stefan Blankenberg, Professor

The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several risk and prognostic factors in major chronic diseases.

A random sample of 45.000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, will take part in an extensive baseline assessment at a dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting cardiac, arterio-venous and cerebral function and structure including extensive imaging examinations. The protocol includes self-ratings of life style and environmental conditions, , dietary habits, physical activity, professional life, psychosocial context, , digital media use, medical and family history as well as health care utilization patterns. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to develop complex models predicting health outcomes based on a multitude of examination data, imaging data and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia will be invited for a visit to conduct additional MRI examination either of heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and data from involved health and pension insurances.

serum, plasma (EDTA, citrate), genomic deoxyribonucleic acid (DNA), ribonucleic acid (RNA) from whole blood and peripheral blood mononuclear cells (PBMCs), blood cells (erythrocytes, PBMCs), urine, saliva, tooth fluid, tonsils swabs

Hamburg City Health Study - a German Cohort Study

A Single Center, Prospective, Epidemiologic Cohort Study With Emphasis on Imaging to Improve the Identification of Individuals at Risk for Major Chronic Diseases and to Improve Early Diagnosis and Survival

coronary artery disease atrial fibrillation heart failure dementia stroke cancer such as prostate cancer and skin cancer chronic kidney diseases migraine musculoskeletal diseases such as osteoporosis and bone metastasis ocular diseases such as glaucoma, macular degeneration, fundus hypertonicus, retinal vessel disease and neoplasm oral health including periodontal disease, oropharyngeal cancer and human papillomavirus (HPV)-infection psychiatric and psychosomatic disorders such as mental disorder or late - last depression pulmonary diseases such as obstructive lung disease sexual disorder skin diseases such as psoriasis, chronic wounds and inflammation vascular diseases such as aortic aneurysm, thrombosis and peripheral arterial disease

Universitäres Herzzentrum Hamburg-Eppendorf

Martini-Klinik am UKE GmbH

Universitätsklinikum Hamburg-Eppendorf

Digestive System Diseases

Dental Plaque

Dysbiosis

Stomatitis

Xerostomia

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Salivary Gland Diseases

Dental Deposits

Quality of Life

Other Dietary Supplements

Acidophilus

Bifidobacterium

An envelope with the same packaging, size, shape and color will be given, it will only differ from the placebo in that it will contain the active ingredient of the intervention which is Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus.Experimental group

The placebo will be given in an envelope with the same packaging, size, shape and color of contents as the intervention of interest, except that the placebo will not contain the active ingredient of the intervention

Each patient should take 1 sachet per day, dissolve it in a glass of water, hold in the mouth for 2-3 minutes and then swallow, for a period of 30 days.

The probiotic to be used in the intervention corresponds to PRODEFEN Plus manufactured by ITALFARMACO S.A. laboratory

The placebo will be administered in an envelope with the same packaging, size, shape and color of contents as the intervention of interest, except that the placebo will not contain the active ingredient of the intervention.

Placebo

Tanya Pereira Riveros, Msc

The study is a Clinical Trial and the main objective is to Evaluate the effects of probiotics on oral complications induced by antineoplastic therapies in patients with head and neck cancer, attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), Faculty of Medicine and Health Sciences Bellvitge campus during the period 2022- 2024.

Research question:

Is the use of probiotics compared to placebo effective in reducing oral complications produced by antineoplastic therapies in patients with head and neck cancer attended in the radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet and the Dental Hospital of the University of Barcelona, Faculty of Medicine and Health Sciences campus Bellvitge during the period 2022- 2024?

Study population: Patients attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), (Master of Dentistry in Oncology and Immunocompromised Patients) diagnosed by histological confirmation of head and neck cancer and treated in the last year.Intervention:

Patients who agree to participate in the study will be randomized to the intervention or control group. Two visits will be made, the first as a baseline measurement and the second after the end of the intervention. In the first visit they will be given the products either probiotic or placebo, with presentation of a box with 10 sachets. The probiotics contain: Lactobacillus Rhamnosus GG, Lactobacillus casei, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacterium infantis and Lactobacillus bulgaricus. 1 x 10e10 Colony Forming Units (CFU). And the placebo composed of excipients. They are gluten free. Each patient will be given 1 sachet dissolved in water, to take 2-3 minutes of mouthfuls then swallow, after brushing, once a day, for 30 days.

Background: The side effects of antineoplastic therapies of the head and neck aggravate the condition of patients resulting in a decrease in the quality of life. At oral level, they can induce the appearance of certain alterations, this predisposes to an imbalance in the oral microbiota, increasing the presence of acidogenic and cariogenic bacteria. In the oral cavity probiotics are associated with a decrease in the colony forming unit (CFU) count of cariogenic pathogens and inhibition of periodontal pathogens. In addition, they modulate the inflammatory response (humoral and cellular). For this reason, they could be considered a good alternative to modulate the oral microbiota in head and neck oncology patients. Hypothesis: The use of probiotics due to the change of the oral microbiota is associated with a beneficial effect against oral complications produced by radiotherapy, chemotherapy and surgery in patients with head and neck cancer, so that probiotic users will have a greater reduction in oral complications induced by cancer therapies compared to those who do not use probiotics. Objectives: To evaluate the effects of probiotics on oral complications induced by antineoplastic therapies in patients with head and neck cancer, attended at the radiotherapy service of the Catalan Institute of Oncology (ICO) Hospitalet and the Dental Hospital of the University of Barcelona (HOUB), Faculty of Medicine and Health Sciences Bellvitge campus during the period 2022- 2024. Methodology: Randomized Clinical Trial during the period 2022-2024. The identification of the population of interest will be patients attended in the radiotherapy service at the Catalan Institute of Oncology (ICO) Hospitalet and at the Dental Hospital of the University of Barcelona (HOUB), in the Master of Dentistry and in Oncology and Immunocompromised Patients. Data will be collected by electronic record, clinical examination, microbiological and radiographic analysis of the participants. Expected results: The use of probiotics is expected to provide a greater reduction in oral complications induced by head and neck antineoplastic therapies. Statistical analysis: Comparison of categorical variables chi-square test, numerical variables Student's test for independent samples and paired samples or Mann-Whitney U test and Wilcoxon signed-rank test. Relative risk with 95% confidence interval. An intention-to-treat analysis will be performed.

Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC

Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With Head and Neck Cancer: Randomized Clinical Study

Analyzed through microbiological qPCR study with 16 S sRNA primers, real-time quantitative PCR and comparative analysis with conventional culture looking for changes in the total count of the following periodontopathogens: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Campylobacter rectus, Fusobacterium nucleatum and Candida culture.

It will be measured by sialometry, analyzing unstimulated salivary secretion and stimulated salivary secretion

It will be measured through paper strips, in one of the containers with accumulated saliva.

It will be measured through a clinical analysis, taking into account the World Health Organization (WHO) mucositis assessment scale.

Measured by clinical examination according to SEPA (Spanish Society of Periodontology) criteria for the classification of periodontal disease.

It will be analyzed based on the quality of life questionnaire for head and neck cancer patients EORTC QLQ-H\&N35 Spanish version.

University of Barcelona

Principal Investigator

Breast Neoplasms

Antineoplastic Agents

Anastrozole

Aromatase Inhibitors

Postmenopausal women with breast cancer taking Arimidex, Aromasin, or Femara

Healthy volunteer postmenopausal women not taking Aromatase Inhibitors

L. Susan Taichman, RDH MPH PhD

The purpose of this study is to determine how aromatase inhibitors (AIs) such as Arimidex, Aromasin or Femara affect a woman's oral health and oral health related quality of life. Patients, dental professionals and medical oncologists will benefit from a greater understanding of the best oral care follow up practices of breast cancer survivors using aromatase inhibitors.

OBJECTIVES:

Primary

This cross-sectional prevalence study seeks to investigate the incidence and severity of oral health changes, specifically of periodontal conditions, among breast cancer survivors and the ways in which these outcomes affect their quality of life.

Secondary

* To determine the prevalence and severity of oral conditions in postmenopausal women with early stage breast cancer using adjuvant AI therapy as compared to postmenopausal women not using adjuvant AI therapy.
* To determine if adjuvant AI therapy use is associated with greater alveolar bone loss or increased levels of bone turnover biomarkers in postmenopausal women with cancer undergoing adjuvant AI therapy compared to postmenopausal women not receiving AI therapy.
* To determine the oral health-related quality of life among postmenopausal women with early stage breast cancer who are receiving adjuvant AI therapy.

Each patient will have 5ml of blood collected at the visit. Saliva, and urine will also be collected at the study visit.

Oral Health in Breast Cancer Survivors on Aromatase Inhibitors

National Institute of Dental and Craniofacial Research (NIDCR)

University of Michigan

Mammary Neoplasms, Animal

Breast Diseases

Central Nervous System Depressants

Anesthetics

The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia.

The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.

Non surgical periodontal Treatment

Aim: This study evaluated the effects of non-surgical periodontal therapy (NSPT) on the cytokine profile and the correlation to clinical parameters of patients undergoing chemotherapy for breast cancer.

Materials and methods: 40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding on probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.

40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding of probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.

Women with cancer and without breast cancer between 35 and 70 years of age

Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy

Effects of Non-surgical Periodontal Treatment on the Gingival Crevicular Fluid Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy

De- identified individual participant for all primary and secundary outcome measures will be made available

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tobacco Cessation Intervention Study for Oral Diseases	NCT02737176	Smoking Cessati... Mouth Diseases Periodontal Dis... Leukoplakia Lichen Planus Keratosis Implant	Tobacco cessati...	20 Years -	Association for the Japanese Academy of Maxillofacial Implants
Post-radiation Dental Disease Amongst Head and Neck Cancer Patients	NCT03703648	Head and Neck C... Caries, Dental Periodontal Dis... Radiotherapy Si...	Radiotherapy (c...	18 Years -	Belfast Health and Social Care Trust
Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus	NCT03910205	Periodontal Dis...	ELISA	7 Years - 14 Years	Aydin Adnan Menderes University
Hamburg City Health Study - a German Cohort Study	NCT03934957	Coronary Heart ... Stroke Dementia Cancer Health Care Vascular Diseas... Periodontal Dis... Ocular Diseases Respiratory Dis... Obesity		45 Years - 74 Years	Universitätsklinikum Hamburg-Eppendorf
Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC	NCT06122636	Quality of Life Oral Mucositis Dental Plaque Periodontal Dis... Xerostomia Dysbiosis	The probiotic t... Placebo	18 Years -	University of Barcelona
Oral Health in Breast Cancer Survivors on Aromatase Inhibitors	NCT01693731	Periodontal Dis... Quality of Life		-	University of Michigan
Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy	NCT03244943	Mammary Neoplas... Periodontal Dis... Chemotherapy Ef...	Non surgical pe...	35 Years - 70 Years	University of Sao Paulo
Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC	NCT06122636	Quality of Life Oral Mucositis Dental Plaque Periodontal Dis... Xerostomia Dysbiosis	The probiotic t... Placebo	18 Years -	University of Barcelona
Periodontal Status and Endothelial Dysfunction in Patients With Polycystic Ovary Syndrome	NCT06184412	Periodontal Dis...		18 Years - 45 Years	Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Spots Global Cancer Trial Database for periodontal diseases