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

Conditions

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

  • Italy
      • Milan, Italy, 20142
        • Recruiting
        • Univeristy of Milan
        • Contact:

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).
Other: Application of CaP dental mousse
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

University of Milan

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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