Comparative Evaluation Of ChlorhexidineGluconate With Graphene Oxide Solution As Irrigant For Pulpectomy Of Primary Teeth – A Randomized Clinical Trial

Phase 2/3

Completed

• Conditions: Dental caries, unspecified,

• Registration Number: CTRI/2023/10/058234
• Lead Sponsor: DrZeel Shah

Brief Summary

Aim: To Compare Chlorhexidine Gluconate with Graphene Oxide Solution as irrigating agent for pulpectomy in primary teeth.

Objectives: ï‚¢ To evaluate the anti-microbial efficacy of Graphene Oxide Solution as irrigating solution ï‚¢ To evaluate the antimicrobial efficacy of CHX and Graphene Oxide Solution in the primary teeth root canals using Culture tests.

Material/equipment for the study: Diagnostic Kit Endodontic Kit 2% Chlorhexidine Gluconate 2% Graphene Oxide Solution Irrigation Syringe Sterile Paper Points Culture Media Eppendorf Tubes

Methodology: ï‚¢ This study will be performed in patients visiting Department of Paediatric and Preventive Dentistry, NPDCH, Visnagar. 25 children (50 teeth) will be included in the study according to selection criteria. ï‚¢ Ethical clearance for carrying out the study will be obtained prior from the Institutional Ethics Committee (IEC) before starting the study. Study will be carried out only after written informed consent from each patient and parents. ï‚¢ After patient selection, LA administration and rubber dam isolation will be done. ï‚¢ Caries excavation and access opening will be done conventionally using airoter and burs. ï‚¢ Pulp tissue will be extirpated. ï‚¢ Irrigation with Normal Saline will be done and working length will be taken ï‚¢ 1 st sample (S1) will be collected prior to instrumentation by using sterile paper points inserted up to working length for 1 minute. Several Samples will be taken at once for culture tests. ï‚¢ Biomechanical preparation will be completed in the same visit using 20ml of one of the solutions (2% CHX or 2% GO) as irrigating solution. First solution to be used will be decided by the Lottery method. ï‚¢ 2 nd sample (S2) will be collected post instrumentation with same method. ï‚¢ Samples (S1 and S2) will be put in Nutrient Broth and sent to laboratory for cultural analysis to count the growth of bacterial isolates. The colony-forming unit (CFU) counts from the predisinfection sample (S1) will serve as a baseline for comparing the reduction in the CFU count post-irrigation (S2).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-15
• Study Completion: 2023-11-16
• Last Update Posted: 2024-07-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 1. Patients aged between 4 and 9 years 2) Patients requiring Pulpectomy in 2 teeth.
• 3. Teeth with intact roots or more than 2/3rd of root present.

Exclusion Criteria

1. Teeth with excessive root resorption and mobility 2) Children with special health care conditions 3) Children who have taken antibiotic medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CFU is lesser after using graphene oxide solution	CFU counts from baseline (Before) and after irrigation (AFTER) with any of the solution

Secondary Outcome Measures

Name	Time	Method
graphene oxide solution possesses more antimicrobial efficacy than chlorhexidine gluconate	Before (baseline) without using irrigating solution & after using irrigation with any of the solution

Trial Locations

Locations (1)

Narsinhbhai Patel Dental College and Hospital; 🇮🇳 Mahesana, GUJARAT, India

Narsinhbhai Patel Dental College and Hospital

🇮🇳Mahesana, GUJARAT, India

Dr zeel shah

Principal investigator

79843465365

Shah.zeel6649@gmail.com