| CTRI Number |
CTRI/2025/07/092041 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Oil Pulling and Gum Disease with Scientific Outlook |
|
Scientific Title of Study
|
A clinico microbiological study on efficacy of oil pulling technique in management of patients with stage 1 periodontitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RADHIKA SINGH |
| Designation |
Postgraduate Student |
| Affiliation |
Institute of dental sciences pilibhit byepass road Bareilly Uttar pradesh |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh
Bareilly
UTTAR PRADESH
243006
India
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9760613666 |
| Fax |
|
| Email |
radhikasingh26071994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Singh |
| Designation |
Reader |
| Affiliation |
Institute of dental sciences pilibhit byepass road Bareilly Uttar pradesh |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh
Bareilly
UTTAR PRADESH
243006
India
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7081222230 |
| Fax |
|
| Email |
akkisingh014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Singh |
| Designation |
Reader |
| Affiliation |
Institute of dental sciences pilibhit byepass road Bareilly Uttar pradesh |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh
Bareilly
UTTAR PRADESH
243006
India
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7081222230 |
| Fax |
|
| Email |
akkisingh014@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh India 243006 |
|
|
Primary Sponsor
|
| Name |
Radhika Singh |
| Address |
Room no 228 Department of Periodontology and Implantology Institute of dental sciences Pilibhit byepass road Bareilly Uttar pradesh India 243006 |
| 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 AKANKSHA SINGH |
Institute of dental sciences pilibhit byepaas road Bareilly Uttar pradesh India 243006 |
Room no 228 Department of Periodontology and Implantology
Bareilly
UTTAR PRADESH |
7081222230
akkisingh014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE,IDS,BAREILLY,UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CHLORHEXIDINE (CONTROL) |
Participants will be instructed to use 1 tablespoon (5ml) each of flaxseed oil and 0.12% chlorhexidine for mouth swishing on empty stomach and or before brushing for 5 minutes every day in the morning for 30 days |
| Comparator Agent |
FLAX SEED OIL (TEST GROUP) |
Participants will be instructed to use 1 tablespoon (5ml) each of flaxseed oil and 0.12% chlorhexidine for mouth swishing on empty stomach and or before brushing for 5 minutes every day in the morning for 30 days |
| Intervention |
OIL PULLING TECHNIQUE |
Participants will be instructed to use 1 tablespoon 5 ml each of flax seed oil and 0.12% chlorhexidine for mouth swishing on empty stomach and or before brushing for 5 minutes every day in the morning for 30 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with age group between 25 to 60 years
Diagnosis of periodontal disease Stage 1 periodontitis with probing pocket depth greater than equal to 4 mm and Clinical attachment loss 1 to 2 mm |
|
| ExclusionCriteria |
| Details |
1.Systemic illnesses affecting periodontal disease.
2.Allergic to flax seed.
3.Alcohol and tobacco consumers (in whatever form).
4.Females- pregnant or nursing.
5.Patient taking antibiotic or anti-inflammatory drug therapy in the preceeding 6 months.
Patient who has underwent dental treatment for past three months |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate various clinical parameters at baseline and after 1 month follow up.
2.To determine colony forming units in plaque samples at baseline and after 1 month follow up. |
0 DAY AND 1 MONTH |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of oil puling with flax seed oil and chlorhexidine mouthwash on clinical parameters. |
1 MONTH 0 DAY |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
20/08/2025 |
| 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
|
Oil pulling, an age-old ayurvedic technique, has attracted attention primarily due to its possible benefits for dental health. Swishing oil around the mouth was the traditional method of oil pulling, which was said to lower pathogenic micro flora, improve oral hygiene, and boost general health With a particular focus on the decrease of colony forming units in the oral cavity, this study compared the effects of oil pulling with flax seed oil and chlorhexidine on oral health. Because of its distinct makeup flax seed oil was thought to have antibacterial properties that were on par with or even better than chlorhexidine The results of this study may offer insightful information on the potential of natural oils as workable substitutes or supplements to conventional chemical agents in oral hygiene regimens Since there is paucity of research on oil pulling, so there is a need for assessment and it would be a beneficial outcome if supported with evidence |