Tooth cavity disinfetion with Chitosan solution in 5-12 year old childre
Phase 3
Completed
- Registration Number
- CTRI/2023/06/053795
- Lead Sponsor
- Dr Sreejeeta Dey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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