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The effect of a calcium delivery system on tooth decay in head and neck cancer patients treated by radiotherapy

Anticariogenic efficacy of a saliva biomimetic in a randomised trial of head-and-neck cancer patients undergoing radiotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14942820
Enrollment
24
Registered
2017-10-31
Start date
2010-05-31
Completion date
Unknown
Last updated
2017-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental caries Oral Health Dental caries

Interventions

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

Sponsors

National Dental Centre Singapore
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Singapore

Contacts

Public ContactEdwin Liu

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026