| CTRI Number |
CTRI/2026/03/106288 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Chlorhexidine versus tulsi leaves and Avocado seed extract as cavity disinfectant in patients with deep dental caries in lower molar teeth |
|
Scientific Title of Study
|
Comparative evaluation of 2 percent Chlorhexidine Solution versus Tulsi Leaves(Ocimum sanctum) and Avocado seeds(Persea americana) Extract as Cavity Disinfectant against Streptococcus mutans and Lactobacillus in Class I deep carious mandibular molars of patient aged 18 to 50 years-A Randomized Controlled 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 |
Sneha Menghwani |
| Designation |
Post Graduate Resident |
| Affiliation |
MGVs KBH Dental College and Hospital,Nashik |
| Address |
Department number 502,Department of Conservative Dentistry and Endodontics, MGVs KBH Dental College and Hospital , Near Raviraj Arcade Mumbai Agra Highway, Panchavati, Nashik.422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
7020981743 |
| Fax |
|
| Email |
snehamenghwani123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surbhi Patel |
| Designation |
Reader |
| Affiliation |
MGVs KBH Dental College and Hospital,Nashik |
| Address |
Department number 502,Department of Conservative Dentistry and Endodontics, MGVs KBH Dental College and Hospital , Near Raviraj Arcade Mumbai Agra Highway, Panchavati, Nashik.422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
9373050500 |
| Fax |
|
| Email |
surbhi17den@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Menghwani |
| Designation |
Post Graduate Resident |
| Affiliation |
MGVs KBH Dental College and Hospital,Nashik |
| Address |
Department number 502,Department of Conservative Dentistry and Endodontics MGVs KBH Dental College and Hospital , Near Raviraj Arcade Mumbai Agra Highway, Panchavati, Nashik.422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
07020981743 |
| Fax |
|
| Email |
snehamenghwani123@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGVs KBH Dental College and Hospital, Department of Endodontics, Panchavati, Nashik,
Maharashtra, India 422003 |
|
|
Primary Sponsor
|
| Name |
Sneha Menghwani |
| Address |
MGVs KBH Dental College and Hospital, Department of Endodontics, Panchavati, Nashik, Maharashtra,India 422003 |
| 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 Sneha Menghwani |
MGVs KBH Dental College and Hospital, Panchavati Nashik,Maharashtra,India 422003 |
Room no 502,Department of Endodontics
Nashik
MAHARASHTRA |
7020981743
snehamenghwani123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH DENTAL COLLEGE-INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 percent Chlorhexidine Solution used as Gold standard Cavity Disinfectant |
2 percent Chlorhexidine Solution will be applied to the prepared cavity using sterile microbrush after caries excavation for 60 seconds and gently air dried before restoration |
| Intervention |
Avocado seed extract |
Standardized avocado seed extract will be applied to the prepared cavity using sterile microbrush after caries excavation for 60 seconds and rinse after that with saline before restoration |
| Intervention |
Tulsi Leave Extract |
Standardized tulsi leaf extract solution will be applied to the prepared cavity using sterile microbrush after caries excavation for 60 seconds and rinse with saline before restoration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having age between 18 to 50 years
2) Systemically healthy and co-operative patients will be selected
3)Mandibular permanent first and second molar having deep class I caries with no tenderness on percussion ,no clinical or radiographic involvement of pulp, and should have normal pdl space and intact lamina dura with diagnosis of reversible pulpitis
4) Patients willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1) Teeth with extensive caries that is approaching pulp.
2) Patient having developmental anamolies of teeth .
3) Tooth having presence of swelling and sinus tract
4) Patient who had received analgesic or antibiotic in past 4 weeks
5) Presence of periapical lesion
6) Teeth with prior history of restoration
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean reduction in colony forming unit(CFU/ml) of streptococcus mutans and lactobacillus before and after disinfection of the cavity means reduction between baseline (after caries excavtion) and post disinfectant application |
Baseline (after caries excavation) and, Immediately after application of disinfectant (post-intervention) in same visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| percentage reduction in Colony forming unit among three groups following application of cavity Disinfectant |
Baseline (after caries excavation) & ,Immediately after application of disinfectant (post Intervention)in same visit |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 4 |
|
Date of First Enrollment (India)
|
30/03/2026 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Dental caries is one of the most prevalent oral diseases caused primarily by cariogenic bacteria such as Streptococcus mutans and Lactobacillus. Complete elimination of microorganisms from deep dentinal caries is essential to prevent secondary caries and pulpal complications. Chlorhexidine is widely used as a cavity disinfectant; however, there is growing interest in herbal alternatives with antimicrobial properties. This randomized, parallel group, multiple arm clinical trial aims to compare the antimicrobial efficacy of 2percent chlorhexidine solution, tulsi (Ocimum sanctum) leaf extract, and avocado (Persea americana) seed extract as cavity disinfectants in Class I deep dentinal caries in mandibular molars among patients aged 18–50 years. Dentinal samples will be collected after caries excavation (baseline) and after application of the respective disinfectant. The primary outcome measure will be reduction in colony forming units (CFU/ml) of Streptococcus mutans and Lactobacillus. The study intends to evaluate whether herbal extracts can serve as effective alternatives to conventional disinfectants in restorative dentistry. |