Mouth and Tooth Diseases

All Conditions

Neoplasms

Pulpitis

Head and Neck Neoplasms

Dental Pulp Diseases

Tooth Diseases

Stomatognathic Diseases

Root canal treatment and crown restoration

Pre-radiation one day root canal treatment and CAD/CAM chair side fabricated crowns for head and neck cancer patients

Root canal treatment and crown

Frank Setzer, DMD, PhD, MS

Pilot study involving 20 patients undergoing dental treatment prior to radiation therapy. Comparison of outcome parameters to existing data of age and gender matched patients.

Advanced radiation therapy systems are part of head/neck cancer treatment. 2-3 weeks prior to the initiation of radiation therapy (preRT), patients undergo dental screening, simple restorations and the removal of teeth deemed a osteoradionecrosis risk, often including asymptomatic, vital teeth. Time limitations preRT generally prohibit a traditional multi-visit approach for endodontic treatment, crown preparation, and an externally fabricated restoration. Precision restorative dentistry, with CAD/CAM milled ceramic restorations allow for immediate post-endodontic rehabilitation on the same. The Center for Clinical and Translational Research (CCTR) at PDM conducts the ARMOR trial, a randomized, controlled trial testing the efficacy of two oral care protocols enrolling 120 cancer patients from the Perelman Center for Advanced Medicine (PCAM) over 3.5 years. This pilot study will enroll 20 patients of the ARMOR trial for endodontic treatment and restoration of posterior asymptomatic and vital teeth using microscopic endodontics and digital precision CAD/CAM restoration. These teeth would otherwise be extracted due to time limitations preRT. Patients will be seen for the dental treatment within the time window from diagnosis to initiation of radiation therapy. Patients will be evaluated for (1) feasibility of the suggested protocol (primary objective); quality of life as in the ARMOR trial; 2) tooth survival; 3) endodontic status \[PAI index\]; 4) periodontal prognosis and status \[McGuire-Nunn Criteria, etc\]; and 5) restorative status \[USPHS Criteria, etc\] (secondary objectives) at 1,2,5 months follow-ups of the ARMOR trial. For control, data for tooth survival and QLQ will be compared to 20 other participants of the ARMOR trial (10/10 per study arm) that do not participate in the EndoRest substudy and to 20 other matching participants patients (age, gender) from an existing, comparable dataset of the ORA-RAD studies of the Penn Study arm at PDM Oral Medicine. Periodontal status and restorative status (iff applicable) will be compared to contra-lateral or counter-arch teeth of the individual participant.

This study involves a modified, expedited tooth restoration procedure for individuals scheduled to undergo radiation therapy for head and neck cancer.

Endodontic-Restorative Pre-Radiation Therapy of Head and Neck Cancer Patients

A Clinical Trial Pilot Study Investigating a New Dental Protocol for Pre-Radiation Endodontic-Restorative Therapy of Head and Neck Cancer Patients

No individual participant data will be made available to other researchers.

Evaluation of whether the proposed one-day root canal treatment plus crown restoration protocol can be utilized and executed prior to radiation treatment of head and neck cancer patients. The evaluation will be on a per patient, not per tooth, basis. Failure is defined as the inability to complete endodontic treatment and definitive restoration of a qualifying tooth in a study participant, resulting in the need for pre-radiation extraction of the tooth.

Evaluation of whether the onset of radiation therapy was delayed due to participation in the EndoRest study. The evaluation will be on a per patient, not per tooth, basis. Delay in RT start will be scored on the following scale:

5 points: RT started as planned; no delays 4 points: RT delayed by 1 day due to participation in the EndoRest study 3 points: RT delayed by 2 days due to participation in the EndoRest study 2 points: RT delayed by 3 days due to participation in the EndoRest study 0 points: RT delated by 4 or more days due to participation in the EndoRest study

The total points for all participants in the study will be summed. A score of \>=90 indicated that the protocol is feasible. A total score \<90 indicates that the protocol is not feasible.

Evaluation of whether a qualifying tooth for which endodontic and restorative treatment was successfully completed was extracted in the time interval post-radiation therapy up to 5 months after the initial visit.

Quality of life and function will be assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) with the Head and Neck specific questionnaire add-on (HN43). This questionnaire assesses general quality of life as well as issues specific to head and neck cancer patients (e.g. difficulty swallowing, pain, dry mouth).

All questions on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire EORTC-QLQ are assigned a score of 0-100. A higher score indicates a higher response level (for function questions, a high score indicates a high level of function, indicating a better outcome. For symptom questions, a high score indicates a high level of symptomology, indicating a worse outcome).

Tooth survival after completion of endodontic-restorative treatment will be assessed in all participants using standard survival analysis techniques.

Endodontic status will be assessed using the periapical index (PAI). PAI uses a scale of 0-5, with 0 meaning "healthy" and 5 meaning "severe periodontitis with exacerbated features."

Periodontal status will be assessed through probing depths of periodontal pockets of the treated tooth.

Restoration status will be assessed using United States Public Health System (USPHS) criteria. The USPHS criteria assesses anatomical form, marginal adaptation, color match, marginal discoloration, surface roughness, and caries, in a single assessment tool. Higher scores indicate less favorable outcomes.

School of Dental Medicine

Abramson Cancer Center at Penn Medicine

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Musculoskeletal Diseases

Eye Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Blood and Lymph Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Syndrome

Diabetes Mellitus

Sjogren's Syndrome

Dental Caries

Sarcoidosis

Cystinosis

Tooth Demineralization

Lymphoproliferative Disorders

Lymphatic Diseases

Hypersensitivity

Hypersensitivity, Delayed

Lysosomal Storage Diseases

Metabolism, Inborn Errors

Genetic Diseases, Inborn

Metabolic Diseases

This study will examine saliva samples from healthy volunteers and patients with various diseases to learn more about how disease affects the mouth and salivary glands. It will use a method called salivary proteomics to identify multiple proteins in saliva and discover if there are protein patterns unique to specific diseases. The study will:

* Characterize the salivary proteome in patients with Sjogren's syndrome, graft-versus-host disease, diabetes, sarcoidosis, cystinosis, dental caries, and immunodeficiencies and in patients who have had head and neck radiation
* Evaluate the possible use of salivary proteomics for early diagnosis
* Evaluate the potential use of salivary proteomics for prognosis and treatment

Patients participating in NIH clinical studies who have Sjogren's syndrome, graft-versus-host disease, diabetes, sarcoidosis, cystinosis, dental caries, or an immunodeficiency, or patients undergoing head and neck radiation may be eligible for this study. Candidates are screened with a medical and dental history, head and neck examination, and photographs of any mouth sores or disease. Healthy volunteers also have blood drawn for routine laboratory testing.

Participants have saliva collected from the floor of the mouth, the parotid salivary glands in the cheek, and the submandibular and sublingual salivary glands under the tongue. Patients with certain diseases also provide a urine sample. Saliva samples are collected as follows:

* One time from healthy volunteers and patients with Sjogren's syndrome, diabetes, sarcoidosis, cystinosis and immunodeficiencies
* Five times from patients undergoing stem cell transplant: at baseline before transplant and about 1, 2, 3 and 6 months after transplant.
* Three times from patients undergoing head and neck radiation: at baseline before radiation and at 3 and 6 months after the conclusion of radiation.

The diagnostic potential of the proteomic methods has been explored by several groups in recent years. Saliva contains many proteins, some of which are altered in various disease states. In this study, saliva is to be sampled in patients with head and neck radiation, diabetes, hematopoietic stem cell transplant, Sjogren's syndrome, cystinuria, methylmalonic acidemia and other conditions. Various novel analytical and data-processing tools will be used to infer characteristic salivary protein and salivary analyte signatures of these disorders. In some cases, these data will be evaluated with data for the oral flora present in the saliva and plaque of these patient groups and relate the presence and levels of particular bacteria to the proteomic profile.

Salivary Proteins in Disease and Health

Salivary Proteomics in Disease and Health

National Institute of Dental and Craniofacial Research (NIDCR)

Nervous System Diseases

Brain Neoplasms

All Drugs and Chemicals

Amino Acids

Fluorides

Fluorides, Topical

Protective Agents

Proline

self-care prevention on diet, oral hygiene and fluoridated toothpaste 1450 ppm with checkup every second month with one occasion of fluoride varnish at the clinic.

a patient-centered education on diet, oral hygiene and fluoridated toothpaste 5000ppm with check up´s and topical fluoride application (varnish) every second month.

Fluoride

Nicklas Strömberg, Prof

Anna Westerlund, Ass Prof

Nicklas Stromberg, Prof

Dental caries affects billions of people worldwide and involves saliva immunodeficiency, commensal pathogen and exposure (lifestyle) causal subtypes of the disease. Up to 85% of adolescents in Swedish and other low prevalence populations are caries-free while the remaining 15% show high, recurrent caries activity. Accordingly, there is a lack of cost-effective risk assessment and prevention tools for personalized oral care. This randomized adaptive clinical trial (RCT) evaluates both caries prevention based on genetic etiology and risk, as a consequence of saliva immunodeficiency genes specifying individuals as susceptible or resistant to caries, and the effect of intensified versus selfcare traditional prevention on the two groups.

This is a protocol for a multicenter risk assessment and intervention study (PRECARIES) with an adaptive component. The study design comprises a prescreen of 2000 adolescents of which 520 will be included in the RCT study part with adolescents undergoing ordinary orthodontic treatment with multibrackets at the Public Dental Service. The orthodontic treatment allows for rapid caries development and improved discrimination between susceptible versus resistant individuals. The children are genotyped into two risk groups; genetic susceptible and non-susceptible children that are assigned to intensive or traditional standard prevention. The clinical outcomes will adaptively be measured at different time points (0, 6, 12 and months) as caries lesions at different teeth and surfaces using tactile, visual and X-ray bitewing, clinical photos and quantitative laser fluorescence (QLF). Secondary outcomes will be inflammation at the gingival margins and pocket depth at debonding of the orthodontic appliances. Questionaires are collected as well as biological samples; swab-dna, whole and parotid saliva and microbiota. Human and microbiota geno-and protein typing involves in and ex house platforms adaptively.

Participant is not informed about if they are in the control or intervention group Outcome assessor are not aware of group allocation Both dentist/nurse and patient do not know the genotype or risk group. Caries registration at start and end will be performed by a dentist not involved in giving the orthodontic treatment or prevention to each patient

Evaluation of Caries Prevention Based on Genetic Etiology and Risk.

Evaluation of Caries Prevention Based on Genetic Etiology and Risk: Protocol for a Multicenter Randomized Controlled and Adaptive Trial for Oral Personalized Care (PRECARIES)

Sociodemographic data (sex and ethnicity), oral hygiene, intake frequency of sweets (e.g., cookies, biscuits, ice cream or dried fruit) and sugary drinks (never, once per month, once per week, several times per week, once per day, several times per day), and the use of extra fluoride

The % change in ΔDeFS caries increment over a follow up period of 6 and 24 months related to prevention.

The baseline and prospective caries scores for incidence and progression of lesions related to risk group

Bleeding on probing quadrant 3, Gingival inflammation will be represented by the index Bleeding on probing (BoP). BoP will be performed at the buccal surfaces in the third quadrant of the mouth approximately 21 surfaces

Mineralization disturbances in enamel, including fluorosis, molar-incisor-hypo-mineralization, amelogenesis imperfecta are noted in the clinical examinations and by viewing clinical photographs and QLF technique.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endodontic-Restorative Pre-Radiation Therapy of Head and Neck Cancer Patients	NCT04996641	Pulpitis - Irre... Caries Head and Neck C...	Root canal trea...	18 Years -	Abramson Cancer Center at Penn Medicine
Salivary Proteins in Disease and Health	NCT00100204	Diabetes Mellit... Sarcoidosis Dental Caries Sjorgren's Synd... Cystinosis Head and Neck N...		-	National Institutes of Health Clinical Center (CC)
Salivary Proteins in Disease and Health	NCT00100204	Diabetes Mellit... Sarcoidosis Dental Caries Sjorgren's Synd... Cystinosis Head and Neck N...		-	National Institutes of Health Clinical Center (CC)
Evaluation of Caries Prevention Based on Genetic Etiology and Risk.	NCT05600517	Caries,Dental	Fluoride	13 Years - 23 Years	Umeå University

Spots Global Cancer Trial Database for caries

Every month we try and update this database with for caries cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for caries

Every month we try and update this database with for caries cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for caries cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.