| CTRI Number |
CTRI/2026/01/101438 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative assessment of total bacterial load in Orthodontic Patients undergoing fixed mechanotherapy subjected to different mouthrinses |
|
Scientific Title of Study
|
Comparative assessment of total bacterial load in Orthodontic Patients undergoing fixed mechanotherapy subjected to different mouthrinses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Kumar Jain |
| Designation |
Professor and Head, Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Saveetha Dental College and Hospital, Chennai |
| Address |
162, Poonamallee high road
Chennai
TAMIL NADU
600077
India |
| Phone |
9884729660 |
| Fax |
|
| Email |
ravindrakumar@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Kumar Jain |
| Designation |
Professor and Head, Department of Orthodontics and Dentofacial Orthopaedics |
| Affiliation |
Saveetha Dental College and Hospital, Chennai |
| Address |
162, Poonamallee high road
Chennai
TAMIL NADU
600077
India |
| Phone |
9884729660 |
| Fax |
|
| Email |
ravindrakumar@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishika Singla |
| Designation |
Resident |
| Affiliation |
Saveetha Dental College and Hospital, Chennai |
| Address |
Saveetha Dental College, Department of Orthodontics, Clinic 27
162, Poonamallee high road, Chennai- Tamil Nadu- 600077
Chennai
TAMIL NADU
600056
India |
| Phone |
09810803406 |
| Fax |
|
| Email |
152308002.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College
162, Poonamallee high road, Chennai- Tamil Nadu- 600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
162, Poonamallee high road, Chennai- Tamil Nadu- 600077 |
| Type of Sponsor |
Private medical college |
|
|
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 Rishika Singla |
Saveetha Dental College and Hospital, Chennai |
Department of Orthodontics, clinc 27,
162, Poonamallee high road, Chennai- Tamil Nadu- 600077
Chennai
TAMIL NADU |
09810803406
152308002.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospital Institutional Ethics Committee |
Approved |
| Saveetha Dental College Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
different mouthrinses |
Probiotic mouthwash
Oil pulling mouthwash
Frequency- once a day for 60 days, 1 hour after brushing at night.
Dose- 10ml for each participant
Duration- 60 seconds |
| Comparator Agent |
mouthrinse |
Chlorhexidine (control group)
Frequency- once a day for 60 days, 1 hour after brushing at night.
Dose- 10ml for each participant
Duration- 60 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Subjects undergoing fixed orthodontic treatment with metal brackets and using conventional elastic ligatures.
Subjects falling under FAIR score in Debris index.
Subjects having full set of permanent dentition. |
|
| ExclusionCriteria |
| Details |
Subjects with a history of antibiotic use in 3–4 weeks before the start of the study.
Subjects with any significant medical history
during the last 1 month.
Subjects having very poor oral hygiene. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| total bacterial load |
T1 (during orthodontic treatment)
T2 (after 2 months of use of mouthrinse) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque scores |
T1 (during orthodontic treatment)
T2 (after 2 months of use of mouthrinse) |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
28/01/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [152308002.sdc@saveetha.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This interventional clinical study aimed to evaluate and compare the effectiveness of three different mouthrinses—probiotic, oil pulling, and chlorhexidine—in reducing the total bacterial load in orthodontic patients undergoing fixed mechanotherapy. Using quantitative real-time PCR (qPCR) for precise microbial assessment, bacterial DNA was extracted from plaque samples collected before and after a 30-day intervention. The results showed that all three interventions significantly reduced bacterial counts, with chlorhexidine showing the greatest reduction, followed by oil pulling and probiotics. The study highlights the potential of natural adjuncts like oil pulling and probiotics as effective and better-tolerated alternatives to chemical agents like chlorhexidine, especially for long-term oral microbial management during orthodontic treatment. |