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To compare the effectiveness of two treatments: Decay preventive solution with a sugar substitute and with a milk protein derivative in children having cavities at an early age.

Comparative Evaluation of the Antimicrobial Efficacy of Fluoride Varnish with Xylitol and Fluoride Varnish with CPP-ACP in children with Early Childhood Caries : A Randomized Clinical Study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085276
Enrollment
44
Registered
2025-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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: Fluoride Varnish with Xylitol: FluoroDose varnish consists of 5% sodium fluoride or 22,600 ppm of fluoride with xylitol. The xylitol sweetener provides added anti-bacterial properties.

Sponsors

Dr Shivika Soral
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children who have Early Childhood Caries (ECC). 2. Healthy children with a behaviour rating of 3 or 4 according to Frankl Scale. 3. Teeth with International Caries Detection and Assessment System (ICDAS) score 1-3. 4. Participants whose parents will give written consent for the study.

Exclusion criteria

Exclusion criteria: 1. The teeth with spontaneous pain, swelling, fistula, abscess or tenderness on percussion. 2. Children allergic fluoride. 3. Children with oral ulceration. 4. Children suffering from any illness or any systemic disease requiring special medical care.

Design outcomes

Primary

MeasureTime frame
The microbiological analysis will be done to assess the S mutans colonies after the application of fluoride varnish in children.Timepoint: The follow up will be done at 3 and 6 months interval.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Shivika Soral

KM Shah Dental College and Hospital

drseemabargale@gmail.com7016048359

Outcome results

None listed

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