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Tooth cavity disinfetion with Chitosan solution in 5-12 year old children

Clinical Evaluation of the efficacy of Phosphorylated Chitosan as Cavity Disinfectant in Carious Primary Molars - NILL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053795
Enrollment
96
Registered
2023-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

None listed

Interventions

Intervention1: Phosphorylated chitosan: low molecular weight chitosan from Sigma aldrich 5% (w/v) of chitosan dissolved in 0.5% (v/v) acetic acid solution, followed by addition of 25 g of urea and 50

Sponsors

Dr Sreejeeta Dey
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Mandibular and maxillary primary molars 2.Moderately deep cavities (ICDAS II caries score 4,5,6) limited to single-surface occlusal lesions and two-surface lesions (mesial-occlusal, MO or distal-occlusal, DO) without buccal/lingual extension 3.systemically healthy and cooperative children(Frankl scale 3 and 4) Radiographic criteria: 4.Lesions involving enamel and not more than half the dentinal thickness with two-third of remaining root length

Exclusion criteria

Exclusion criteria: 1.Systemic illness 2.Patients undergoing orthodontic treatment 3.Carious lesions involving pulp with/without root resorption and mobility 4.Re-restorations/hypomineralised teeth 5.Uncooperative patients(Frankl scale 1 and 2) Withdrawal criteria: 6.Development of allergy

Design outcomes

Primary

MeasureTime frame
To assess & compare the increase or decrease in bacterial activity with the use of p-chitosan & conventional chlorhexidine cavity disinfectants by measuring mean carious lesion area using fluorescence image analysisTimepoint: 1 month

Secondary

MeasureTime frame
To evaluate & compare the efficacy of p-chitosan cavity disinfectant with that of conventional chlorhexidine disinfectant in the retention and longevity of a dental restoration using FDI clinical scoring criteriaTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Sreejeeta Dey

JSS Dental College and Hospital

seema.pedo@gmail.com8880505064

Outcome results

None listed

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