Clinical trial NCT06308796: Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy
Official title: Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Head and Neck Cancer
Radiotherapy; Complications
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* previous head and neck radiotherapy for oncological treatment

Exclusion Criteria:

* complete edentulism
* pregnancy or breastfeeding

Primary outcomes:
measure: Number of new cavitated caries per each patient (incidence of caries)
timeFrame: Assessment every 3 months up to 2 years
Secondary outcomes:
measure: Number of extracted teeth per patient (incidence of extracted teeth)
timeFrame: Assessment every 3 months up to 2 years
measure: Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis)
timeFrame: Assessment every 3 months up to 2 years
measure: Number of dental surfaces with caries or filling, and missed teeth
timeFrame: Assessment every 3 months up to 2 years
measure: Rate of dentinal hypersensitivity per patient
timeFrame: Assessment every 12 months up to 2 years
measure: Rate of dental surface with plaque per patient
timeFrame: Assessment every 3 months up to 2 years
measure: Rate of bleeding gingival sites per patient
timeFrame: Assessment every 3 months up to 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Univeristy of Milan
Study officials:
References:
citation: 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.
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.
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.
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.