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

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Contents

clinicaltrials.gov/study/NCT06308796
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT063087960
Health Conditions in Trial
Head and neck cancer
Head and neck cancer
0
Trial Recruitment Size
400
Trial Sponsor
University of Milan
University of Milan
0
Clinical Trial Start Date
April 1, 2023
0
Primary Completion Date
January 31, 2026
0
Study Completion Date
March 31, 2026
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Other0
Interventional Trial Phase
Not Applicable0
Official Name
Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy: a Randomized Controlled Trial0
Last Updated
March 13, 2024
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
Application of CaP dental mousse0
Study 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.

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