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

University of Milan

Status: Enrolling

Conditions: Radiotherapy; Complications; Caries,Dental; Head and Neck Cancer

Treatments: Other: Application of CaP dental mousse

Study type: Interventional

Funder types: Other

Identifiers

NCT06308796

RADIOCARIES2023

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• previous head and neck radiotherapy for oncological treatment

Exclusion criteria

• complete edentulism
• pregnancy or breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

CaP + Fluoride

Experimental group

Description:

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).

Treatment:

Other: Application of CaP dental mousse

Only fluoride

No Intervention group

Description:

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.