Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy (RADIOCARIES)
March 13, 2024 updated by: Elena Varoni, University of Milan
Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy: a Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Milan, Italy, 20142
- Recruiting
- Univeristy of Milan
-
Contact:
- Elena M Varoni, PhD
- Phone Number: +3950319017
- Email: elena.varoni@unimi.it
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- previous head and neck radiotherapy for oncological treatment
Exclusion Criteria:
- complete edentulism
- pregnancy or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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).
|
Application of calcium phosphate (CaP) mousse on dental surfaces at home, once a day for 3 months; followed, as maintenance, once a day for just one week a month.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of new cavitated caries per each patient (incidence of caries)
Time Frame: 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)
|
Assessment every 3 months up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of extracted teeth per patient (incidence of extracted teeth)
Time Frame: Assessment every 3 months up to 2 years
|
Number of new teeth extracted
|
Assessment every 3 months up to 2 years
|
|
Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis)
Time Frame: Assessment every 3 months up to 2 years
|
Number of new areas of bone necrosis
|
Assessment every 3 months up to 2 years
|
|
Number of dental surfaces with caries or filling, and missed teeth
Time Frame: Assessment every 3 months up to 2 years
|
Recording of the diseased, missed, filled surfaces (DMFS) index
|
Assessment every 3 months up to 2 years
|
|
Rate of dentinal hypersensitivity per patient
Time Frame: 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)
|
Assessment every 12 months up to 2 years
|
|
Rate of dental surface with plaque per patient
Time Frame: 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)
|
Assessment every 3 months up to 2 years
|
|
Rate of bleeding gingival sites per patient
Time Frame: 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)
|
Assessment every 3 months up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Breslin M, Taylor C. Incidence of new carious lesions and tooth loss in head and neck cancer patients: a retrospective case series from a single unit. Br Dent J. 2020 Oct;229(8):539-543. doi: 10.1038/s41415-020-2222-2. Epub 2020 Oct 23.
- El-Rabbany M, Duchnay M, Raziee HR, Zych M, Tenenbaum H, Shah PS, Azarpazhooh A. Interventions for preventing osteoradionecrosis of the jaws in adults receiving head and neck radiotherapy. Cochrane Database Syst Rev. 2019 Nov 20;2019(11):CD011559. doi: 10.1002/14651858.CD011559.pub2.
- Palmier NR, Migliorati CA, Prado-Ribeiro AC, de Oliveira MCQ, Vechiato Filho AJ, de Goes MF, Brandao TB, Lopes MA, Santos-Silva AR. Radiation-related caries: current diagnostic, prognostic, and management paradigms. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jul;130(1):52-62. doi: 10.1016/j.oooo.2020.04.003. Epub 2020 May 19.
- Tao S, Zhu Y, Yuan H, Tao S, Cheng Y, Li J, He L. Efficacy of fluorides and CPP-ACP vs fluorides monotherapy on early caries lesions: A systematic review and meta-analysis. PLoS One. 2018 Apr 30;13(4):e0196660. doi: 10.1371/journal.pone.0196660. eCollection 2018.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
January 31, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
February 2, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 13, 2024
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RADIOCARIES2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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