Neoplasms

All Conditions

Mouth and Tooth Diseases

Head and Neck Neoplasms

Dental Caries

Tooth Demineralization

Tooth Diseases

Stomatognathic Diseases

All Drugs and Chemicals

Bone Density Conservation Agents

Fluorides

Fluorides, Topical

Calcium

Calcium, Dietary

Irradiated head and neck cancer patients receiving topical CaP mousse to be applied at home (once a day for the first 3 months, then once a day for one week per month as maintenance), besides topical fluoride (F) in form of professional varnishes (every 6 months) and home products (once a day oral rinse with F mouthwash; three times a day toothpaste with brushing).

Irradiated head and neck cancer patients receiving only topical fluoride (F) in form of professional varnishes (every 6 months) and home products (once a day oral rinse with F mouthwash; three times a day toothpaste with brushing). Topical fluoride is included in the standard of care, according to national and international guidelines.

Application of calcium phosphate (CaP) mousse on dental surfaces at home, once a day for 3 months; followed, as maintenance, once a day for just one week a month.

Application of CaP dental mousse

Elena M Varoni, PhD

One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions.

Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy

Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy: a Randomized Controlled Trial

Identification of new carious lesion using International Caries Detection and Assessment System from score 0 initial lesions to 6 large cavitated lesions (ICDAS; 4-6)

Recording of the diseased, missed, filled surfaces (DMFS) index

Dentine Hypersensitivity Experience Questionnaire: the higher the score, the greater the impact of dentin sensitivity on daily life (items have coded responses on 7-point Likert scales: 1 = "strongly disagree", 2 = "disagree", 3 = "agree a little", 4 = "neither agree nor disagree", 5 = "disagree a little", 6 = "disagree" and 7 = "strongly disagree"; a total score is then calculated)

Recording of full mouth plaque score (FMPS) (from 0 no plaque to 100% all dental surfaces with plaque)

Recording of full mouth bleeding score (FMPS) (from 0 no plaque to 100% all gingival sites bleeding)

University of Milan

Associate Professor

Nervous System Diseases

Brain Neoplasms

Amino Acids

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
Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy	NCT06308796	Caries,Dental Head and Neck C... Radiotherapy; C...	Application of ...	18 Years -	University of Milan
Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy	NCT06308796	Caries,Dental Head and Neck C... Radiotherapy; C...	Application of ...	18 Years -	University of Milan
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,dental