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Fluoride varnish application for the control of radiation induced dental caries in head and neck cancer patients

Comparative evaluation of fluoride varnish versus fluoride varnish with cpp-acp to control the radiation caries among irradiated head & neck cancer patients - a one year randomised controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050724
Enrollment
72
Registered
2023-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: C021- Malignant neoplasm of border of tongue Health Condition 2: C020- Malignant neoplasm of dorsal surface of tongue Health Condition 3: C022- Malignant neoplasm of ventral surface of tongue Health Condition 4: C01- Malignant neoplasm of base of tongue Health Condition 5: C060- Malignant neoplasm of cheek mucosa Health Condition 6: C061- Malignant neoplasm of vestibule ofmouth Health Condition 7: C062- Malignant neoplasm of retromolar area Health Condition 8: C100- Malignant

Interventions

Intervention1: Fluoride varnish with cpp-acp: Fluoride varnish with cpp-acp will be applied pre-radiotherapy and at 3 months interval till 1 year. Control Intervention1: Fluoride varnish: Fluoride var

Sponsors

Hitesh kumar sahoo
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with head and neck cancer who are planning for/undergoing RT with more than 50Gy of radiation, with or without chemotherapy,Patients whose oral cavity lies within the RT field during treatment,Patients of 21 years of age or older,Patients having at least two remaining teeth after oral health clearance,Patients having no known milk allergy,Patients who are able to give informed consent.

Exclusion criteria

Exclusion criteria: Patients who have received RT previously,Patients who are receiving RT for palliative care,Patients with edentulous upper and lower jaws,Patients with a habit of mouth breathing.

Design outcomes

Primary

MeasureTime frame
DMFSTimepoint: Baseline(pre-rt),3 months,6 months,9 months and 12 months

Secondary

MeasureTime frame
Schiff score , Patient complianceTimepoint: Baseline(pre-rt),3 months,6 months,9 months and 12 months

Countries

India

Contacts

Public ContactDrUtkal Keshari Mohanty

S.C.B.Dental College and Hospital,Cuttack

utkalcommunity@gmail.com9437953285

Outcome results

None listed

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