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

Head and Neck Cancer Clinical Trial

— RADIOCARIES  

Official title:

Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308796
• Other study ID #: RADIOCARIES2023
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• previous head and neck radiotherapy for oncological treatment

Exclusion Criteria:

• complete edentulism

• pregnancy or breastfeeding

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	Univeristy of Milan	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of extracted teeth per patient (incidence of extracted teeth)	Number of new teeth extracted	Assessment every 3 months up to 2 years
Secondary	Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis)	Number of new areas of bone necrosis	Assessment every 3 months up to 2 years
Secondary	Number of dental surfaces with caries or filling, and missed teeth	Recording of the diseased, missed, filled surfaces (DMFS) index	Assessment every 3 months up to 2 years
Secondary	Rate of dentinal hypersensitivity per patient	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
Secondary	Rate of dental surface with plaque per patient	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
Secondary	Rate of bleeding gingival sites per patient	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