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

NCT06308796 | Recruiting

• 1 other identifier: RADIOCARIES2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries,Dental; Head and Neck Cancer; Radiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

• Number of new cavitated caries per each patient (incidence of caries)

  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 Outcomes (6)

• Number of extracted teeth per patient (incidence of extracted teeth)

  Assessment every 3 months up to 2 years

• Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis)

  Assessment every 3 months up to 2 years

• Number of dental surfaces with caries or filling, and missed teeth

  Assessment every 3 months up to 2 years

• Rate of dentinal hypersensitivity per patient

  Assessment every 12 months up to 2 years

• Rate of dental surface with plaque per patient

  Assessment every 3 months up to 2 years

Study Arms (2)

CaP + Fluoride

EXPERIMENTAL

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

Only fluoride

NO INTERVENTION

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.

Interventions

Application of CaP dental mousse OTHER

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.

CaP + Fluoride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• previous head and neck radiotherapy for oncological treatment

You may not qualify if:

• complete edentulism
• pregnancy or breastfeeding

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Univeristy of Milan

Milan, 20142, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 33097891 BACKGROUND

• 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.

  PMID: 31745986 BACKGROUND

• 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.

  PMID: 32444333 BACKGROUND

• 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.

  PMID: 29709015 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: March 13, 2024
• Study Start: April 1, 2023
• Primary Completion: January 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)