| CTRI Number |
CTRI/2024/02/063000 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
14/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the antimicrobial efficacy of liquorice and chlorhexidine (1%) gel as cavity disinfectants in deciduous molars |
|
Scientific Title of Study
|
“A Randomized Controlled Trial to Compare the Antimicrobial Efficacy of Licorice and CHLORHEXIDINE (1%) GEL as cavity disinfectants in deciduous molars†|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Wajiha khan |
| Designation |
PG student |
| Affiliation |
Sudha rustagi college of dental science and research faridabad |
| Address |
room number 6
department of pedodontics
sudha rustagi college of dental science and research faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9711760277 |
| Fax |
|
| Email |
wajiha.khan4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhavna gupta saraf |
| Designation |
HOD |
| Affiliation |
Sudha rustagi college of dental science and research faridabad |
| Address |
room number 6
department of pedodontics
sudha rustagi college of dental science and research faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9899124779 |
| Fax |
|
| Email |
guptabhavna2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavna gupta saraf |
| Designation |
HOD |
| Affiliation |
Sudha rustagi college of dental science and research faridabad |
| Address |
room number 6
department of pedodontics
sudha rustagi college of dental science and research faridabad
Faridabad
HARYANA
121002
India |
| Phone |
9899124779 |
| Fax |
|
| Email |
guptabhavna2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SUdha rustagi College of dental science and research
Room number 6
Paediatric and preventive dentistry
Faridabad |
|
|
Primary Sponsor
|
| Name |
DR WAJIHA KHAN |
| Address |
Room number 6,
Department of paediatric and preventive dentistry
Sudha rustagi college of dental science and research |
| Type of Sponsor |
Other [] |
|
|
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 WAJIHA KHAN |
Sudha rustagi dental college |
Room number 6
Department of paediatric and preventive dentistry
Sudha rustagi dental college
Faridabad
HARYANA |
9711760277
wajiha.khan4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SRCDSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- CHLORHEXIDINE GLUCONATE (1%) |
1% chlorhexidine Di gluconate which is commercially available as Hexigel. will be applied at the baseline and for 1 minute. Total duration of application is 1 minute at the base line. Chlorhexidine is a gold standard agent with prolonged broad-spectrum antimicrobial abilities efficiently reducing counts of mutans streptococci and Lactobacillus. Different formulations of chlorhexidine (liquid and gel forms) have been used to reduce the number of cariogenic bacteria in the saliva |
| Comparator Agent |
Group 3-NORMAL SALINE (CONTROL GROUP) |
Normal saline will be taken as the control group . A 2ml syringe will be filled with normal saline applied at the baseline and the cavity will be rinsed with it for 1 minute. Total duration of application is 1 minute at the baseline. Normal saline simply physically flushes the debris out of the cavity and the root canals since it is chemically inert. It is well known that periapical tissues as well as soft tissues are biocompatible with normal saline. Without having any antibacterial properties, it cannot eliminate the smear layer; this can be inferred from the results smallest reduction in total viable count |
| Intervention |
LIQUORICE |
LIQUORICE is commercially available as Powder- 500G .100mg of liquorice agent will be prepared freshly by adding 1 ml glycerol to form a gel just before performing the restoration procedure and which is applied as baseline and 1 minute after application. Total duration of application is 1 minute at the base line.
Glycyrrhiza glabra Linn., commonly known as liquorice, is known to have therapeutic effects to relieve coughs, sore throats, and gastric inflammation. Recent research suggests that attributing to its anti-adherence, antimicrobial, and anti-inflammatory properties, liquorice and its various bioactive ingredients (glycyrrhizol A) have potential effects against cariogenic bacteria |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Children with deep dentinal carious deciduous teeth with no symptoms, signs and radiographic findings pertained to irreversible pulpitis( abscess, fistula, sinus) were selected. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| a study is planned to evaluate and compare the antimicrobial effectiveness of Liquorice (Mulethi) and Chlorhexidine (1%) gel in children aged 5 to 9 years old as cavity disinfectants. |
Liquorice (Mulethi) and Chlorhexidine (1%) gel in children and normal saline are applied as baseline and 1 minute after application the samples will be taken. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate & comparison of the antimicrobial efficiency of pre & post-application of liquorice as cavity disinfectant.
2. To evaluate & comparison of the antimicrobial efficiency of pre & post-application of chlorhexidine (1%) gel as cavity disinfectant.
3. To evaluate & comparison of the antimicrobial efficiency of post-liquorice & post-chlorhexidine (1%) gel as cavity disinfectant.
4. To evaluate & comparison of the antimicrobial efficiency of post-liquorice & post-chlorhexidine (1%) gel with saline (control) as cavity disinfectants.
|
liquorice, chlorhexidine gel & normal saline samples will be taken at baseline & 1 minute after application of agents |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
28/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Background: It is
pivotal to eliminate any remaining bacteria present on the cavity walls, in the
smear layer, at the enamel–dentin junction, or in the dentinal tubules after
removal of the carious dentin. In recent years, there has been an increase in the
practice of "phytotherapeutics" or "ethnopharmacology,"
which is the study of natural treatments as a part of medical and dental
therapy as cavity disinfectants.
Aim: This study aims to evaluate and compare the antimicrobial effectiveness of
LIQUORICE(MULETHI)AND CHLORHEXIDINE (1%) GEL with normal saline(as control) in children aged 5 to 9 years old, as cavity
disinfectants.
Materials and methods: In
this study, a total of 84 subjects (28 per group) within the age group of 5 to 9 years
will be included and will be randomly divided into three groups: Group I [Hexigel
containing Chlorhexidine gluconate (1%) gel], Group II [Liquorice],
and Group III [Normal saline] as a Control group.
The sample will be collected by excavating carious
dentine before disinfection. After disinfecting the cavities with test agents,
samples will be again collected and forwarded to the college’s microbiological
laboratory for a total viable count of bacteria. The Kruskal Wallis test,
Mann-Whitney U test and the Wilcoxon paired t-test will be used to statistically
analyze the given data.
|