DENTOFACIAL-PBT Stage 2 - Feasibility Study [Version 1.0]
Research type
Research Study
Full title
DENtofacial TOxicity: Facilitating Advancement in paediatric Cancer toxIcity reporting And Liaison in Proton Beam Therapy stage 2 [DENTOFACIAL-PBT(2)].
IRAS ID
335067
Contact name
Emma Foster-Thomas
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
What is the health problem? \nProton beam therapy (PBT), a type of radiotherapy treatment, can be especially beneficial to children and teenagers with cancer. PBT works by damaging cancer cells, but it can also damage healthy parts of the body nearby. This can include the teeth and jaws if the cancer is in the head and neck region. Unfortunately, we do not yet fully understand the potential side effects of PBT on the teeth or jaws. \n\nWhat is the aim?\nThe DENTOFACIAL-PBT research project aims to learn about the side effects to the teeth and jaws in children treated with PBT. This stage of the research aims to determine how frequently issues (‘toxicities’) in the development of the teeth and growth of the jaws have occurred in previously treated patients. DENTOFACIAL-PBT is funded by the National Institute for Health and Care Research.\n\nHow is the researched being approached?\nWe will ask head and neck childhood cancer survivors treated with PBT overseas or in Manchester to support this research. Surveys will be sent initially, asking questions about their teeth and jaws after treatment. If interested, these survivors can be involved in the next part of this stage, which is a mixed-methods feasibility study. This will involve online interviews and dental assessments with some and the collection of dental information from a participant’s dentist. Radiation dose to the teeth and the jaw bones will then be linked to any side effects seen.\n\nWhat will be the outcome?\nThe information gained in this study will allow the research team to look at how age, location and amount of dose given affects the toxicities seen. Information learnt will help develop the final stage of the DENTOFACIAL-PBT study. In this, a new toxicity reporting tool will be developed which aims to improve the communication between dentists, doctors, and cancer patients.
REC name
North of Scotland Research Ethics Committee 2
REC reference
25/NS/0092
Date of REC Opinion
19 Aug 2025
REC opinion
Favourable Opinion