| CTRI Number |
CTRI/2025/07/091985 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Natural and Medicinal Mouthwashes: Evaluating the Role of Pulling Oil and Chlorhexidine in Oral Health |
|
Scientific Title of Study
|
Effectiveness of Pulling Oil Versus Chlorhexidine Mouthwash in reducing plaque induced gingivitis: A RANDOMISED 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 |
Poonam |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College Raipur CG |
| Address |
Department of Public Health Dentistry
Government Dental College Raipur CG
Raipur
CHHATTISGARH
492001
India |
| Phone |
87705155509 |
| Fax |
|
| Email |
pnarang0988@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Milind Wasnik |
| Designation |
Professor & HOD |
| Affiliation |
Government Dental College Raipur CG |
| Address |
Department of Public Health Dentistry
Government Dental College Raipur CG
Raipur
CHHATTISGARH
492001
India |
| Phone |
7972199512 |
| Fax |
|
| Email |
drmilind.pcd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College Raipur CG |
| Address |
Department of Public Health Dentistry
Government Dental College Raipur CG
Raipur
CHHATTISGARH
492001
India |
| Phone |
87705155509 |
| Fax |
|
| Email |
pnarang0988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College Raipur
State- Chhattisgarh, Pincode- 492001, Country- India |
|
|
Primary Sponsor
|
| Name |
Dr Poonam Narang |
| Address |
Department of Public Health Dentistry
Government Dental College Raipur CG |
| 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 Poonam Narang |
Government Dental College Raipur CG |
Department of Public Health Dentistry
Government Dental College Raipur CG
Raipur
CHHATTISGARH |
7089089863
pnarang0988@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF GOVERNMENT DENTAL COLLEGE, RAIPUR CG |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouthwash |
Chlorhexidine mouthwash (0.12% chlorhexidine gluconate used as per standard recommendations).
|
| Intervention |
Pulling oil mouthwash |
Commercially available Pulling Oil mouthwash as per the manufacturer’s recommendations, swishing the oil for 10 minutes daily for two weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for this study include adults aged 18–60 years with mild-to-moderate plaque-induced gingivitis who are systemically healthy and have not undergone dental scaling in the last three months. Additionally, participants must be willing to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria include individuals with chronic periodontitis or systemic conditions, pregnant or lactating women, smokers or those with tobacco-related habits, and individuals with known allergies to coconut oil or chlorhexidine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes of this study include the reduction in Plaque Index (PI) and Gingival Index (GI) scores in both groups over time, along with the identification of the antibacterial efficacy of pulling oil compared to chlorhexidine. |
These outcomes will be assessed at baseline, 7th day, and 14th day to evaluate the effectiveness of the interventions.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes focus on identifying safer alternatives to conventional mouthwashes for managing plaque-induced gingivitis and improving the understanding of the role of pulling oil in oral hygiene practices. These findings will help assess the long-term potential of pulling oil as an adjunctive oral care solution. |
These outcomes will be assessed at baseline, 7th day, and 14th day to evaluate the effectiveness of the interventions.
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
09/08/2025 |
| 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="6"
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
|
This randomized parallel active-controlled clinical trial aims to evaluate the effectiveness of pulling oil mouthwash versus chlorhexidine mouthwash in reducing plaque-induced gingivitis. The study will include systemically healthy adults (18–60 years) with mild-to-moderate gingivitis, who will be randomly assigned to either the pulling oil mouthwash group or the chlorhexidine mouthwash group. The primary outcomes include the reduction in Plaque Index (PI) and Gingival Index (GI) scores at baseline, 7th day and 14th day, along with the identification of the antibacterial efficacy of pulling oil. Secondary outcomesfocus on identifying safer alternatives to conventional mouthwashes and understanding the role of pulling oil in oral hygiene practices. The study will follow a single-blind design, with participants blinded to the mouthwash used. Randomization will be conducted using a computer-generated sequence, and allocation concealment will be maintained using sealed opaque envelopes. By integrating clinico-microbiological analysis, behavioral compliance assessment, and cost-effectiveness evaluation, this study aims to provide evidence-based recommendations on the potential role of pulling oil mouthwash in public health dentistry. |