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A school-based study to compare fluoride varnish and fissure sealant for preventing dental caries in 6 9-year-old children in Bhubaneswar

Acceptability and Cost-effectiveness of fluoride varnish versus fissure sealant treatment in preventing dental caries among 6-9 years old children in a school-based setting in Bhubaneswar, Odisha: A clustered Randomized Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111142
Enrollment
290
Registered
2026-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None listed

Interventions

Intervention1: FLUORIDE VARNISH: Children allocated to Group A will receive topical fluoride varnish application on the first permanent molars. Disposable gloves, 5% sodium fluoride varnish, disposabl

Sponsors

Institute of Dental Sciences
Lead Sponsor
Shalini Sahoo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 to 9 years with at least one fully erupted first permanent molar free of cavitated lesions and whose parent or guardian provides informed consent and who assent to participate

Exclusion criteria

Exclusion criteria: Children with systemic illnesses or special health care needs, children who are uncooperative or unwilling to participate, children who received fluoride varnish or sealant treatment in the previous 6 months and children undergoing orthodontic treatment

Design outcomes

Primary

MeasureTime frame
Incidence of new dental caries in first permanent molars assessed by ICDAS criteria.Timepoint: At baseline and at 8 months follou-up after the intervention for evaluating the incidence of new dental caries in first permanent molars assessed according to ICDAS criteria.

Secondary

MeasureTime frame
Acceptability of intervention using Delighted-to-Terrible scale immediately after procedure; Time taken for intervention application during the procedure; Cost-effectiveness of fluoride varnish versus fissure sealantTimepoint: At the end of 8-month study period.

Countries

India

Contacts

Public ContactSHALINI SAHOO

Institute of Dental Sciences

radhadalai@soa.ac.in7381036062

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026