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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
Sponsor:
Collaborator:
Queen's University, Belfast
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

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.


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

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Study Type : Observational
Estimated Enrollment : 215 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Dental caries [ Time Frame: 24-months ]
    The mean number of carious teeth amongst head and neck cancer patients post-radiotherapy


Secondary Outcome Measures :
  1. Periodontal disease [ Time Frame: 24-months ]
    The proportion of head and neck cancer patients with periodontal disease post-radiotherapy.

  2. 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)

  3. 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)

  4. Salivary flow rate [ Time Frame: 6-months, 12-months, 24-months ]
    Change from baseline

  5. Mouth opening [ Time Frame: 6-months, 12-months, 24-months ]
    Change from baseline

  6. 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

  7. 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

  8. Tooth loss [ Time Frame: 6-months, 12-months, 24-months ]
  9. Costs of treatment to patients and NHS [ Time Frame: 6-months, 12-months, 24-months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with a head and neck cancer and treated with radiotherapy (curative intent).
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

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


Contacts
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Contact: Ciaran E Moore, BDS (Hons) 00442890633790 cmoore49@qub.ac.uk
Contact: Gerry McKenna, BDS 00442890633790 g.mckenna@qub.ac.uk

Locations
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United Kingdom
School of Dentistry, Belfast Recruiting
Belfast, Antrim, United Kingdom, BT12 6BA
Contact: Gerry McKenna, PhD, BDS, FDS       g.mckenna@qub.ac.uk   
Principal Investigator: Gerry McKenna, PhD, BDS, FDS         
Sponsors and Collaborators
Belfast Health and Social Care Trust
Queen's University, Belfast
Investigators
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Principal Investigator: Gerry McKenna, BDS Queen's University, Belfast
  Study Documents (Full-Text)

Documents provided by Belfast Health and Social Care Trust:

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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT03703648     History of Changes
Other Study ID Numbers: 17164GMcK-SW
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Belfast Health and Social Care Trust:
Dental caries
Periodontal disease
Head and neck cancer
Radiotherapy
Micro-costings study
Dental health
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Periodontal Diseases
Dental Caries
Stomatognathic Diseases
Neoplasms by Site
Neoplasms
Mouth Diseases
Tooth Demineralization
Tooth Diseases