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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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27 November 2017 |
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Main ID: |
ISRCTN14942820 |
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Date of registration:
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31/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of a calcium delivery system on tooth decay in head and neck cancer patients treated by radiotherapy
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Scientific title:
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Anticariogenic efficacy of a saliva biomimetic in a randomised trial of head-and-neck cancer patients undergoing radiotherapy |
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Date of first enrolment:
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31/05/2010 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN14942820 |
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Study type:
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Interventional |
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Study design:
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Randomized double-blind study (Treatment)
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Phase:
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Edwin
Liu |
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Address:
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National Dental Centre Singapore
5, Second Hospital Avenue
168938
Singapore
Singapore |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients aged 21 years or older
2. Ability to understand and provide informed consent prior to starting the study
3. Patient has no advanced periodontal disease
4. Patient has at least eight remaining teeth at start of the study
Exclusion criteria: 1. Patient who has previously undergone head and neck radiotherapy
2. Uncontrolled systemic disease (eg hypertension, diabetes)
3. Patient on palliative care
4. Pregnancy (self declared)
5. Patient with milk allergy (self declared)
6. Patient with hydroxybenzoates (preservative) allergy (self declared)
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dental caries
Oral Health
Dental caries
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Intervention(s)
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Randomisation was carried out based on a randomisation list generated by the biostatistician. 24 nasopharyngeal carcinoma patients treated with radiotherapy were randomly assigned to the control group (fluoride gel + placebo creme) or the intervention group (fluoride gel + casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) creme). All participants are reviewed at five study visits: two visits before start of radiotherapy, mid-radiotherapy, 2 weeks and 3 months after end of radiotherapy. At each study visit, an oral examination was carried out. Resting saliva was collected and analysed for fluoride ion concentration.
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Primary Outcome(s)
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Caries lesion progression assessed using the International Caries Detection and Assessment System (ICDAS) visual criteria at baseline, 2 weeks and 3 months after completion of radiotherapy
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Secondary Outcome(s)
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Fluoride ion concentration in resting saliva measured using a fluoride-specific electrode at baseline, one week before start of radiotherapy, mid-radiotherapy, 2 weeks and 3 months after end of radiotherapy
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Secondary ID(s)
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CIRB 2010/182/D
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Source(s) of Monetary Support
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National Dental Centre Singapore Research Fund/National Medical Research Council Centre Grant
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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