NCT07057284Enrolling by invitation

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)]

Source: ClinicalTrials.gov · Last updated 26 Jan 2026

Brief summary (registry, in English)

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.

Status (registry): Enrolling by invitation
Study type: Observational
Enrollment: 255 (estimated)
First submitted: 16 May 2025
Start date: 16 Jan 2026
Primary completion date: 30 Sept 2026
Lead sponsor: Manchester University NHS Foundation Trust
Diseases: Head and neck cancer, Childhood cancers
NCT number: NCT07057284

What you commit to

Study type: Observational
Planned participants: 255
From 16 Jan 2026 to the primary completion date, 30 Sept 2026
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

(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.
(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.

Age

(ii) Aged greater than or equal to 16 years old at the time of diagnosis
(iii) Currently aged less than 2 years old
(vi) A parent or person with parental responsibility in law for a CCS now aged greater than 16 years old.
(ii) Aged greater than or equal to 16 years old at the time of diagnosis
(iii) Currently aged less than 2 years old
(vii) A parent or person with parental responsibility in law for a CCS now aged greater than 16 years old.

Other

(i) Deceased patients
(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).
(vii) Exclusion of any participant who does not speak a language specified in the inclusion criteria.
(i) Deceased patients
(iv) Completed PBT less than 12 months ago.
(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.
(ix) Exclusion of any participant who does not speak a language specified in the inclusion criteria.

Who the study is looking for

(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.
(vii) Able and willing to provide informed consent or informed consent provided by a parent or person with parental responsibility in law for a child currently aged less than 16 years old who meets the inclusion criteria outlined in (i) to (vi).
(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.
(ix) Able and willing to provide informed consent or informed consent provided by a parent or person with parental responsibility in law for a child currently aged less than 16 years old who meets the inclusion criteria outlined in (i) to (viii).
(x) Language - English, Arabic, Chinese, Dutch, French, German, Italian, Portuguese, Russian, Spanish and Turkish.

Age in the registry: 2 years to 32 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Manchester University NHS Foundation Trust Coordinator of this site? Confirm its status	Manchester	United Kingdom	Unknown status
The Christie NHS Foundation Trust Coordinator of this site? Confirm its status	Manchester	United Kingdom	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.