DENTOFACIAL-PBT Stage 2 - Feasibility Study
DENtofacial TOxicity: Facilitating Advancement in Paediatric Cancer toxIcity Reporting And Liaison in Proton Beam Therapy. Stage 2 - Feasibility of Retrospective Toxicity Outcome Collection [DENTOFACIAL-PBT(2)]
1 other identifier
observational
255
1 country
2
Brief Summary
What is the health problem? Proton 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, the investigators do not yet fully understand the potential side effects of PBT on the teeth or jaws. What is the aim? The 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. How is the researched being approached? The investigators 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. What will be the outcome? The 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2025
CompletedFirst Posted
Study publicly available on registry
July 9, 2025
CompletedStudy Start
First participant enrolled
January 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
January 26, 2026
June 1, 2025
9 months
May 16, 2025
January 23, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Recruitment rate and number of participants with complete datasets.
Usability and completeness of the study data. A 'complete dataset' for a participant refers to the following: completed survey, cancer diagnosis, treatment and follow-up information, pre- and post- radiotherapy dental radiographs, dental information from a participants dentist and extracted dentofacial dosimetric statistics.
From enrolment until study completion, an average of 1 year.
Presence of dentofacial toxicities
Prevalence of dentofacial toxicities in the UK cohort of paediatric HNC patients treated with PBT.
Through study completion, an average of 1 year.
Secondary Outcomes (8)
Patient perspectives on dentofacial development and toxicities.
From enrolment to the completion of the last study interview, an average of 1 year.
Dental health seeking behaviour and practices.
From enrolment to the completion of the last study interview, an average of 1 year.
Patient-reported dentofacial toxicity outcomes.
From enrolment to study completion, an average of 1 year.
Clinician-reported dentofacial toxicity outcomes
From enrolment to study completion, an average of 1 year.
Extracted radiation dose statistics.
Following collection of all data (30/09/2026)
- +3 more secondary outcomes
Interventions
A dental assessment will be conducted on eligible participants who still attend annual review appointments in the Oncology Departments at the Royal Manchester Children's Hospital or at The Christie NHS Foundation Trust (approximately 10% of eligible study population). The dental assessment will include the following: a tooth chart, a basic periodontal examination (BPE), a brief orthodontic assessment (incisor, molar and skeletal classification including any asymmetry), caries assessment and an assessment of any dental development disturbances. Clinical photographs of the teeth and face will be taken with a patient's consent. If clinically justified, an OPT will be taken. If cooperation for an OPT proves challenging, lateral obliques as an alternative radiographic image modality will be considered.
Eligibility Criteria
Childhood head and neck cancer survivors who were treated with proton beam therapy either in the National Health Service Proton Overseas Programme or at The Christie NHS Foundation Trust.
You may qualify if:
- (i) CCS previously diagnosed with HNC. This includes the oral cavity (lips, front two-thirds of the tongue, the gums, the lining inside the cheeks and lips, the floor of the mouth, under the tongue and the hard palate), the throat (nasopharynx, oropharynx and hypopharynx), the voice box (larynx), the paranasal sinuses, nasal cavity and the salivary glands
- (ii) Any sex.
- (iii) Currently a minimum age of 2 years.
- (iv) Treated with PBT at The Christie PBT centre (Manchester, UK) or treated overseas with PBT as part of the NHS Proton Overseas Programme.
- (v) Completed treatment with PBT when aged 15 years and under.
- (vi) Completed treatment with PBT more than 12 months ago.
- (viii) Language - Capacity to translate study documents and conduct interviews in the following languages: English, Arabic, Chinese, Dutch, French, German, Italian, Portuguese, Russian, Spanish and Turkish.
- (i) CCS previously diagnosed with HNC. This includes the oral cavity (lips, front two-thirds of the tongue, the gums, the lining inside the cheeks and lips, the floor of the mouth, under the tongue and the hard palate), the throat (nasopharynx, oropharynx and hypopharynx), the voice box (larynx), the paranasal sinuses, nasal cavity and the salivary glands.
- (ii) Any sex.
- (iii) Currently a minimum age of 2 years old for a clinical assessment without a radiograph to be conducted. The minimum age of a participant that a radiograph will be attempted at is 3 years old.
- (iv) Referred for PBT treatment by the Oncology team at The Royal Manchester Children's Hospital.
- (v)Treated with PBT at The Christie PBT centre (Manchester, UK) or treated overseas with PBT as part of the NHS Proton Overseas Programme.
- (vi) Completed treatment with PBT when aged 15 years and under.
- (vii) Completed treatment with PBT more than 12 months ago.
- (viii) Attending annual review clinics at either The Royal Manchester Children's Hospital ("follow-up clinic") or at The Christie NHS Foundation Trust ("late effects clinic") with the Oncology team.
- +1 more criteria
You may not qualify if:
- (i) Deceased patients
- (ii) Aged greater than or equal to 16 years old at the time of diagnosis
- (iii) Currently aged less than 2 years old
- (iv) Completed PBT less than 12 months ago. (Although the minimal follow-up time for dentofacial toxicities to develop is unknown, it is felt that setting this restriction will enable eligible participants to have processed their treatment and had multiple reviews within this first year. This criterion of follow-up was discussed with the developed patient advisory group and this timeframe was felt to be the most appropriate).
- (v) Individuals treated with PBT overseas but not referred from a UK centre (not in the Proton Overseas Programme). For example, individuals whose care was privately funded or funded by an insurance company. The PCO Database maintained by the PCOU will not hold outcome data for privately funded patients.
- (vi) A parent or person with parental responsibility in law for a CCS now aged greater than 16 years old.
- (i) Deceased patients
- (ii) Aged greater than or equal to 16 years old at the time of diagnosis
- (iii) Currently aged less than 2 years old
- (iv) Completed PBT less than 12 months ago.
- (v) Individuals treated with PBT overseas but not referred from a UK centre (not in the Proton Overseas Programme). For example, individuals whose care was privately funded or funded by an insurance company.
- (vi) No radiation delivered to the maxilla, mandible and/or teeth.
- (vii) A parent or person with parental responsibility in law for a CCS now aged greater than 16 years old.
- (viii) Living outside of the Greater Manchester region and not attending routine annual clinics with the Oncology team at The Royal Manchester Children's Hospital or at The Christie NHS Foundation Trust.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Manchester University NHS Foundation Trust
Manchester, M13 9WL, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2025
First Posted
July 9, 2025
Study Start
January 16, 2026
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
January 31, 2027
Last Updated
January 26, 2026
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share