Preventing tooth decay in head and neck cancer survivors after radiotherapy
Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy: a Randomized Controlled Trial
This study is testing if a special mousse with calcium phosphate and fluoride can help prevent tooth decay in people who have had radiation treatment for head and neck cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milan Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milan) |
| Trial ID | NCT06308796 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of calcium phosphate (CaP) mousse combined with topical fluoride in preventing dental caries in patients who have undergone radiotherapy for head and neck cancer. The study aims to address the increased risk of tooth decay due to hyposalivation, a common side effect of radiation therapy. Participants will be randomly assigned to receive either the CaP and fluoride treatment or no treatment at all, allowing for a comparison of outcomes. The goal is to determine if the CaP mousse can help remineralize teeth and reduce caries incidence in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are head and neck cancer survivors who have previously undergone radiotherapy.
Not a fit: Patients who are completely edentulous or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of tooth decay in head and neck cancer survivors, improving their oral health and quality of life.
How similar studies have performed: While similar approaches have been explored, this specific combination of CaP and fluoride treatment in this patient population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * previous head and neck radiotherapy for oncological treatment Exclusion Criteria: * complete edentulism * pregnancy or breastfeeding
Where this trial is running
Milan
- Univeristy of Milan — Milan, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.