Post-radiation Dental Disease Amongst Head and Neck Cancer Patients

NCT03703648 | Unknown

• 1 other identifier: 17164GMcK-SW
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

Background Post-radiotherapy head and neck cancer (HANC) patients are at increased risk of dental caries and periodontal disease due to radiation-related damage to the teeth and salivary glands. Currently the exact aetiology of post-radiotherapy dental disease, and variation in its incidence and severity based on tumour location and radiotherapy dose, is poorly understood. Consequently there is a lack of clear guidance on how HANC patients should be dentally managed both before and after their radiotherapy. Aim The aim of this study is to quantify the relationship between dental radiation dose, 'spared' parotid gland radiation dose, tumour location, and post-radiotherapy dental disease. Methods A prospective cohort study will be undertaken in HANC patients treated with radiotherapy. A total of 215 patients will be recruited over a period of 2.5 years. Participants will be assessed and rendered dentally fit prior to radiotherapy in the School of Dentistry, Belfast. All patients will be followed-up at 6, 12, and 24-months post-radiotherapy. Data to be collected at each visit will include: total number of carious teeth, periodontal disease indices, salivary flow rates, diet, oral hygiene, mouth opening, xerostomia and oral health-related quality of life. Radiotherapy, including individual tissue-dose exposures, will be prescribed by the Clinical Oncology team as per current practice. Doses to the teeth and 'spared' parotid gland will be determined using radiotherapy research software (Non-Clinical Eclipse System sold by Varian Medical Systems UK Ltd). Using appropriate statistical tests, data analysis will determine the relationship between dental disease, radiation dose, and tumour location. Anticipated variation in the incidence and severity of post-radiotherapy dental disease based on the radiotherapy dose and tumour location, will inform the development of a clinical risk-assessment tool that will allow dentists to categorise patients as 'high' or 'low' risk of future disease. Guidelines regarding pre-radiotherapy dental extractions and post-radiotherapy preventative strategies will also be developed and will advise clinicians based on this risk assessment. A micro-costings study will be undertaken to evaluate patient and healthcare costs associated with the diagnosis and management of pre- and post-radiotherapy dental disease.

Conditions

Head and Neck Cancer; Caries, Dental; Periodontal Diseases; Radiotherapy Side Effect

Keywords

Dental caries; Periodontal disease; Head and neck cancer; Radiotherapy; Micro-costings study; Dental health

Outcome Measures

Primary Outcomes (1)

• Dental caries

  The mean number of carious teeth amongst head and neck cancer patients post-radiotherapy

  24-months

Secondary Outcomes (9)

• Periodontal disease

  24-months

• Xerostomia measured using the Xerostomia Questionnaire (XQ)

  6-months, 12-months, 24-months

• Oral Health Quality of Life (OHIP-14)

  6-months, 12-months, 24-months

• Salivary flow rate

  6-months, 12-months, 24-months

• Mouth opening

  6-months, 12-months, 24-months

Interventions

Radiotherapy (curative) for head and neck cancer RADIATION

Curative intent radiotherapy for head and neck cancer. Doses will be prescribed by an independent Clinical Oncology team. There will be no alteration or experimentation of radiotherapy dosage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with a head and neck cancer and treated with radiotherapy (curative intent).

You may qualify if:

• \- Adult dentate patients diagnosed with a primary or secondary malignant tumour of the oral cavity, nasal cavity, sinuses, salivary glands, pharynx, or larynx\* requiring radiation treatment within Northern Ireland. \*International Classification of Diseases (ICD-10) codes C00.0-C14.8 and C30.0-32.9.

You may not qualify if:

• Patients deemed to have poor prognosis or to receive palliative treatment only (as advised by the Clinical Oncology team).
• Patients with less than 6 teeth before the radiotherapy start date.
• Patients with recurrent head and neck cancer, or patients receiving a repeat course of head and neck radiotherapy.
• Patients with diseases affecting tooth development (e.g. amelogenesis or dentinogenesis imperfecta) or salivary gland function (e.g. Sjogren's Syndrome).
• Patients with pre-existing trismus (mouth opening less than 35mm).

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Queen's University, Belfast: collaborator

Study Sites (1)

School of Dentistry, Belfast

Belfast, Antrim, BT12 6BA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Dental Caries; Periodontal Diseases; Radiation Injuries

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Mouth Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Gerry McKenna, BDS

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ciaran E Moore, BDS (Hons)

CONTACT

00442890633790; cmoore49@qub.ac.uk

Gerry McKenna, BDS

CONTACT

00442890633790; g.mckenna@qub.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 12, 2018
• Study Start: December 1, 2018
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: January 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)