| CTRI Number |
CTRI/2023/10/058234 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation Of Chlorhexidine
Gluconate With Graphene Oxide Solution As Irrigant For Pulpectomy Of Primary Teeth –
A Randomized Clinical Trial
|
|
Scientific Title of Study
|
Comparative Evaluation of Chlorhexidine Gluconate With Graphene Oxide Solution as Irrigant for Pulpectomy in Primary Teeth - A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Zeel Shah |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Department no 8, Dept of Pediatric and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University,
Ahmadabad
GUJARAT
384315
India |
| Phone |
79843465365 |
| Fax |
|
| Email |
Shah.zeel6649@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shoba Fernandes |
| Designation |
Head of Department |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Department no 8 , department of pediatric and preventive dentistry, Narsinhbhai Patel Dental College and Hospital, Sanklachand patel University,Visnagar
Mahesana
GUJARAT
384315
India |
| Phone |
7567622346 |
| Fax |
|
| Email |
vshobaf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrZeel Shah |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Department No 8 , Department of Pediatric and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar
Ahmadabad
GUJARAT
384315
India |
| Phone |
7984346536 |
| Fax |
|
| Email |
Shah.zeel6649@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narsinhbhai Patel Dental College and Hospital, SPU, Visnagar |
|
|
Primary Sponsor
|
| Name |
DrZeel Shah |
| Address |
Department no 8 , Department of pediatric and preventive dentistry, Narsinhbhai Patel Dental College and Hospital, Visnagar |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr zeel shah |
Narsinhbhai Patel Dental College and Hospital |
Department no 8 , department of pediatric and preventive dentistry, narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar
Mahesana
GUJARAT |
79843465365
Shah.zeel6649@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Narsinhbhai Patel Dental College & Hospital, Sankalchand Patel University, Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chlorhexidine Gluconate |
20ml intracanal for 1 minute |
| Comparator Agent |
Graphene Oxide Solution |
20ml INtracanal |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
1) Teeth with excessive root resorption and mobility
2) Children with special health care conditions
3) Children who have taken antibiotic medication |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CFU is lesser after using graphene oxide solution |
CFU counts from baseline (Before) and after irrigation (AFTER) with any of the solution |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| graphene oxide solution possesses more antimicrobial efficacy than chlorhexidine gluconate |
Before (baseline) without using irrigating solution & after using irrigation with any of the solution |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2023 |
| Date of Study Completion (India) |
16/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/11/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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). |