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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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

Spots Global Cancer Trial Database for application of cap dental mousse