| CTRI Number |
CTRI/2026/02/102838 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
oil pulling |
|
Scientific Title of Study
|
“Comparative Evaluation of Oil Pulling and Chlorhexidine mouthwash in Reducing dental Plaque and Gingival Inflammation: A Randomized Control 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 |
Sakshi Gujarathi |
| Designation |
PG student |
| Affiliation |
Sri Aurobindo College of Dentistry, Indore |
| Address |
104- Maa Vaishno girls hostel,behind luv khush supermarket,near aurobindo hsopital ,indore
Indore MADHYA PRADESH 453555 India |
| Phone |
07083305408 |
| Fax |
|
| Email |
smg240600@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sakshi Gujarathi |
| Designation |
PG student |
| Affiliation |
Sri Aurobindo College of Dentistry, Indore |
| Address |
104- Maa Vaishno girls hostel,behind luv khush supermarket,near aurobindo hsopital ,indore
MADHYA PRADESH 453555 India |
| Phone |
07083305408 |
| Fax |
|
| Email |
smg240600@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sakshi Gujarathi |
| Designation |
PG student |
| Affiliation |
Sri Aurobindo College of Dentistry, Indore |
| Address |
104- Maa Vaishno girls hostel,behind luv khush supermarket,near aurobindo hsopital ,indore
MADHYA PRADESH 453555 India |
| Phone |
07083305408 |
| Fax |
|
| Email |
smg240600@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sakshi gujarathi |
| Address |
SRI AUROBINDO COLLEGE OF DENTISTRY |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SAIMS |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SAKSHI |
SRI AUROBINDO COLLEGE OF DENTISTRY |
department of public health dentistry Indore MADHYA PRADESH |
7083305408
smg240600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PRESENCE WITH STAIN AND CALCULUS |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | oil gargling | (Procedure Reference: , Procedure details: gargling with oil 10ml of oil for 5-10 min)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Participants of age 18 and above
• Able to provide informed consent
• Expected to comply with the protocol.
• Planning to remain at their current address for the next 6 months.
• No history of dental visit in past 6 months.
|
|
| ExclusionCriteria |
| Details |
• Uncooperative patients/patient who is not willing to give consent
• Existing soft tissue damage caused by ill-fitting dental appliances.
• Participants with systemic diseases and under medication for the same.
• Presence of any dental condition which needed prompt professional attention such as: periodontal disease, dental abscess, pain and swelling.
• Using any other commercially available mouthwash
• Participants having any adverse habits. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Currently available mouthwashes in the market to maintain oral hygiene have side effects and are often expensive. Thus, the need of the study arises to recommend oral hygiene method to the community which is better safer and affordable alternative to mouthwashes. |
baseline,3day and 7 days of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TRADITIONAL METHOD OF GARGLING |
baseline 3day & 7 day |
|
|
Target Sample Size
|
Total Sample Size="125" Sample Size from India="125"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
|
·
125 participants will be taken,
subject will be randomly allocated into 5 groups using table of
random numbers. Each group
will be comprised of 25 study subjects.
Group
1: Coconut oil pulling
Group
2: Sesame oil pulling
Group
3: Olive oil pulling
Group
4: Chlorhexidine mouthwash
Group
5: Distilled water (placebo)
·
Subjects will be selected according to inclusion
and exclusion criteria
·
Subjects will be advised to take 5-10 ml using a
table spoon or till the mouth is half filled and sip, suck, pull the liquid
through the teeth. Subjects will be advised to lift their chin a bit; close
eyes and start swishing liquid from left to right, front to back
approximately for 5-10 minutes or till the subjects feel fullness in mouth
and the procedure will be performed prior to the brushing. The participants
will be clearly instructed to take adequate precautions not to swallow the
liquid while demonstrating the procedure. If at all swallowing occurs not to
feel panic or fearful about the procedure.
·
Plaque
levels will be measured using Turesky’s modification of the Quigley Hein
Plaque Index, the condition of the gums will be assessed using the Loe and
Silness Gingival Index and tongue coating will be measured using the Winkel
Tongue Coating Index (WTCI).
·
Data collection will be done at baseline along
with plaque, gingival and tongue coating index. Re-evaluate indices on 7th
day and final evaluation of indices on 14th day. (ANNEXURE-F)
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