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Effectiveness of Sodium Fluoride varnish in adjunction with Chlorhexidine or Povidone iodine versus Sodium Fluoride varnish alone for caries prevention in 12-year olds: A Randomized Controlled Trial

Effectiveness of Sodium Fluoride varnish in adjunction with Chlorhexidine or Povidone iodine versus Sodium Fluoride varnish alone for caries prevention in 12-year olds: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093441
Enrollment
360
Registered
2025-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: K00-K14- Diseases of oral cavity and salivary glands

Interventions

Intervention1: 10% Povidone Iodine and 5% Chlorhexidine: Around 0.3 ml of 10% Povidone Iodine and same amount of Chlorhexidine will be used at once in 6 months and will be applied 3 times in 18 months

Sponsors

Dr Abhishek
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: I. Persons willing to participate. II. Participants living in the same area since birth. III. At least 16 teeth are present. IV. Coronal caries with ICDAS score equal to or less than 3.

Exclusion criteria

Exclusion criteria: (I) Participants with systemic disorders. (II) Participants not giving consent. (III) Uncooperative participants. (IV) Hypoplastic teeth. (V) Patients with severe gingivitis, or other conditions where maintenance of oral hygiene is not possible. (VI) Participants undergoing orthodontic treatment. (VII) Participants taking any active treatment. (VIII) Participants who took antibiotic drugs in the last 1 month. (IX) Participants involved in any other trial.

Design outcomes

Primary

MeasureTime frame
(I) Net caries increment assessed by subtracting the number of reversed or remineralized lesions from the total number of new lesions recorded at follow- up. Active lesions will only be consideredTimepoint: (ii) S. mutans Bacterial colony count

Secondary

MeasureTime frame
(ii)Streptococcus Mutans colony count at first & second follow upTimepoint: At 6 & 12 months after baseline

Countries

India

Contacts

Public ContactAbhishek

Post Graduate Institute of Dental Sciences,Rohtak

adarsh.pgids@uhsr.ac.in8397974518

Outcome results

None listed

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