DENTOFACIAL-PBT Stage 2 - Feasibility Study

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.

Conditions

• Head and Neck Cancer
• Radiotherapy Side Effect
• Adverse Effect of Radiation Therapy
• Childhood Cancer
• Dental Developmental Disorders and Anomalies
• Facial Deformity
• Jaw; Developmental Disorder
• Radiation Toxicity

Interventions

RADIATION

Orthopantomogram (or a set of Lateral Oblique Radiographs)

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.

Sponsors & Collaborators

• The Christie NHS Foundation Trust

  collaborator OTHER

• Manchester University NHS Foundation Trust

  lead OTHER_GOV

Eligibility

Min Age

2 Years

Max Age

32 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-16

Primary Completion

2026-09-30

Completion

2027-01-31

Countries

• United Kingdom

Study Locations