Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy
- Conditions
- Head and Neck CancerRadiotherapy; ComplicationsCaries,Dental
- Interventions
- Other: Application of CaP dental mousse
- Registration Number
- NCT06308796
- Lead Sponsor
- University of Milan
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- previous head and neck radiotherapy for oncological treatment
- complete edentulism
- pregnancy or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CaP + Fluoride Application of CaP dental mousse 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).
- Primary Outcome Measures
Name Time Method Number of new cavitated caries per each patient (incidence of caries) Assessment every 3 months up to 2 years 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)
- Secondary Outcome Measures
Name Time Method Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis) Assessment every 3 months up to 2 years Number of new areas of bone necrosis
Rate of dentinal hypersensitivity per patient Assessment every 12 months up to 2 years 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)
Rate of bleeding gingival sites per patient Assessment every 3 months up to 2 years Recording of full mouth bleeding score (FMPS) (from 0 no plaque to 100% all gingival sites bleeding)
Number of extracted teeth per patient (incidence of extracted teeth) Assessment every 3 months up to 2 years Number of new teeth extracted
Number of dental surfaces with caries or filling, and missed teeth Assessment every 3 months up to 2 years Recording of the diseased, missed, filled surfaces (DMFS) index
Rate of dental surface with plaque per patient Assessment every 3 months up to 2 years Recording of full mouth plaque score (FMPS) (from 0 no plaque to 100% all dental surfaces with plaque)
Trial Locations
- Locations (1)
Univeristy of Milan
🇮🇹Milan, Italy