| CTRI Number |
CTRI/2025/11/097182 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate the antimicrobial property of flaxseed oil and coconut oil |
|
Scientific Title of Study
|
An invivo study to evaluate the antimicrobial property of flaxseed oil and coconut oil |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SWAPNIL PARLANI |
| Designation |
Vice Dean Professor and HOD |
| Affiliation |
Peoples college of dental sciences and research centre |
| Address |
Department of Prosthodontics
Room number G3
Ayodhya bypass road
Bhanpur Bhopal
Madhya Pradesh
India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9893243002 |
| Fax |
|
| Email |
swapnil.p@peoplesuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SWAPNIL PARLANI |
| Designation |
Vice Dean Professor and HOD |
| Affiliation |
Peoples college of dental sciences and research centre |
| Address |
Department of Prosthodontics
Room number G3
Ayodhya bypass road
Bhanpur
Bhopal
Madhya Pradesh
India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9893243002 |
| Fax |
|
| Email |
swapnil.p@peoplesuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saba Hussain |
| Designation |
Professor and HOD |
| Affiliation |
Peoples college of dental sciences and research centre |
| Address |
Department of Microbiology
Room number T3
Ayodhya bypass road
Bhanpur
Bhopal
Madhya Pradesh
India
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9893243002 |
| Fax |
|
| Email |
sabaghayur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples college of dental sciences and research centre
Ayodhya bypass road
Bhanpur Bhopal Madhya Pradesh 462037 India |
|
|
Primary Sponsor
|
| Name |
MP Council of Science and Technology |
| Address |
Vigyan Bhawan Nehru nagar
Bhopal
MP
India 462003 |
| Type of Sponsor |
Government funding agency |
|
|
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 Swapnil Parlani |
Peoples college of Dental Sciences |
Department of Prosthodontics
Room number G3
Ayodhya bypass road
Bhanpur Bhopal
Madhya Pradesh
India 462037
Bhopal
MADHYA PRADESH |
9893243002
swapnil.p@peoplesuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antimicrobial property by using only water for improving oral health of edentulous patients |
Group 3 will be taken as control group
Total duration of the study will be twelve months |
| Intervention |
Antimicrobial property of coconut oil for improving oral health of edentulous patients |
For group 2 implementation of oil pulling method with coconut oil each morning for a duration of one month will be done. The antimicrobial property pre and post intervention will be studied
Total duration will be twelve months |
| Intervention |
Antimicrobial property of flaxseed oil for improving oral health of edentulous patients |
For group 1 implementation of oil pulling method with flaxseed oil each morning for a duration of one month will be done. The antimicrobial property pre and post intervention will be studied. Detection of microflora will be done using culture media
Total duration will be twelve months |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Edentulous subjects |
|
| ExclusionCriteria |
| Details |
dentulous subjects
Subjects with history of coconut oil and flaxseed oil allergies
Subjects with antibiotics use in the past 3-4 weeks
Subjects with history of mouthwash use in past 3-4 weeks |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Short term impact assessment of coconut and flaxseed oil |
data collection and assessment in 64 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Data analysis and reporting after reviewing all the data from short term assessment |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
There is a growing need for safe natural and cost effective method to clean the oral cavity. It is an invivo clinical study which involves edentulous patients to evaluate the antimicrobial properties of flaxseed oil and coconut oil on oral microbiota. Patients will be divided into 3 groups using flaxseed oil coconut oil and one control group. Patients will be adviced to use the oil for oil pulling method for 30 days. Swabs will be collected from oral mucosa and will be cultured to assess microbial load pre and post intervention. Assessment of oral health using oral health assessment tool will also be done. This study will offer another dimension of ayurveda in dentistry which inturn will stop the spread of communicable diseases in a cost effective way. |