Post-radiation Dental Disease Amongst Head and Neck Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03703648|
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : January 21, 2019
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer Caries, Dental Periodontal Diseases Radiotherapy Side Effect||Radiation: Radiotherapy (curative) for head and neck cancer|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||215 participants|
|Official Title:||The Effect of Dental and Salivary Gland Radiation Dose on the Occurrence of Post-radiotherapy Dental Disease in Patients With Head and Neck Cancer|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||May 31, 2023|
- Radiation: Radiotherapy (curative) for head and neck cancer
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
- Dental caries [ Time Frame: 24-months ]The mean number of carious teeth amongst head and neck cancer patients post-radiotherapy
- Periodontal disease [ Time Frame: 24-months ]The proportion of head and neck cancer patients with periodontal disease post-radiotherapy.
- Xerostomia measured using the Xerostomia Questionnaire (XQ) [ Time Frame: 6-months, 12-months, 24-months ]Change from baseline. Range of scores from 0 (no xerostomia) to 90 (worst xerostomia)
- Oral Health Quality of Life (OHIP-14) [ Time Frame: 6-months, 12-months, 24-months ]Change from baseline. 14 oral health problems presented - patients asked to score how often they are personally encountered (very often, fairly often, occasionally, hardly ever, never, don't know)
- Salivary flow rate [ Time Frame: 6-months, 12-months, 24-months ]Change from baseline
- Mouth opening [ Time Frame: 6-months, 12-months, 24-months ]Change from baseline
- Diet assessed by Question 13 of the World Health Organisation's Oral Health Questionnaire for Adults [ Time Frame: 6-months, 12-months, 24-months ]Change from baseline. Respondents asked to detail how often they consume e.g. sugar buns
- Oral hygiene practice assessed by Questions 7,8,9 of the World Health Organisation's Oral Health Questionnaire for Adults [ Time Frame: 6-months, 12-months, 24-months ]Change from baseline. Patients asked to indicate e.g. how often do you brush your teeth
- Tooth loss [ Time Frame: 6-months, 12-months, 24-months ]
- Costs of treatment to patients and NHS [ Time Frame: 6-months, 12-months, 24-months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703648
|Contact: Ciaran E Moore, BDS (Hons)||firstname.lastname@example.org|
|Contact: Gerry McKenna, BDSemail@example.com|
|School of Dentistry, Belfast||Recruiting|
|Belfast, Antrim, United Kingdom, BT12 6BA|
|Contact: Gerry McKenna, PhD, BDS, FDS firstname.lastname@example.org|
|Principal Investigator: Gerry McKenna, PhD, BDS, FDS|
|Principal Investigator:||Gerry McKenna, BDS||Queen's University, Belfast|