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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• previous head and neck radiotherapy for oncological treatment

Locations
Other Locations
Italy
Univeristy of Milan
RECRUITING
Milan
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 40
Treatments
Experimental: CaP + Fluoride
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).
No_intervention: Only fluoride
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.
Related Therapeutic Areas
Sponsors
Leads: University of Milan

This content was sourced from clinicaltrials.gov