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Comparing protective effects of two dental varnish in children with increased risk of tooth decay.

Comparison of therapeutic and prophylactic effect of chlorhexidine varnish with fluoride varnish for active carious lesions in high risk ECC patients using â??4D CariesCareâ?? approach : A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051764
Enrollment
56
Registered
2023-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Group B Chlorhexidine Varnish (Cervitec Plus, Ivoclar): Tooth surfaces shall be cleaned. A dry working field will be created using cotton rolls and a saliva ejector or air syringe if ne

Sponsors

Dr Pallavi Parasramka
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Pediatric Patients diagnosed with Early Childhood Caries (ECC). - Pediatric Patients with more than or equal to two surfaces of primary dentition with active carious lesions at the time of enrolment. - Patients with high caries risk determined under 4D CariesCare approach approach. - Pediatric Patients with atleast two sound surfaces in primary dentition. - Patients of ECC whose parents give consent to participate in the study - Patients with ECC with erupting permanent molars can be included.

Exclusion criteria

Exclusion criteria: - Patients with associated medically compromised conditions - Patients with low caries risk determined under 4D CariesCare approach (Annexure 1) - Patients with developmental disorders of primary teeth affecting the whole primary dentition - Patients in mixed dentition stage involving erupting anterior teeth along with permanent molars - Patients with primary teeth lost due to trauma - Patients with previous history of caries preventive interventions. - Patients with known allergy to any of the constituents of the varnish.

Design outcomes

Primary

MeasureTime frame
1. Number of surfaces with active carious lesions reversed 2. Number of surfaces with active carious lesions controlled 3. Number of surfaces with new active carious lesions Timepoint: At 3months, 6months, 9months

Secondary

MeasureTime frame
1. Number of surfaces with staging of carious lesion reversed 2. Number of surfaces with staging of carious lesion controlled 3. Number of surfaces with staging of carious lesion progressed 4. Change in Oral health related quality of life scores .Timepoint: At 3months, 6months, 9months

Countries

India

Contacts

Public ContactDr Richa Khanna

Faculty Of Dental Sciences, King George Medical University

richa.bahal@gmail.com9936038511

Outcome results

None listed

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