| CTRI Number |
CTRI/2025/07/090473 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of 2 different mouthrinse on plaque induced gingivitis patient with fixed orthodontic appliances |
|
Scientific Title of Study
|
Comparative evaluation of the Efficacy of mouthrinse containing 0.1% Hyaluronic Acid and 0.2% Chlorhexidine gluconate and mouthrinse containing 0.2% Chlorhexidine gluconate alone in plaque induced gingivitis patients with fixed orthodontic appliance: A Clinico- biochemical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JOHNVEE S |
| Designation |
Post graduate student |
| Affiliation |
Yenepoya Dental College |
| Address |
Room 7 2nd floor Department of Periodontology Yenepoya Dental College Yenepoya University
Mangaluru
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9962198874 |
| Fax |
|
| Email |
24286@yenepoya.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh K S |
| Designation |
Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Room 7 2nd floor Department of Periodontology Yenepoya Dental College Yenepoya University
Mangaluru
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448529518 |
| Fax |
|
| Email |
rksdental@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh K S |
| Designation |
Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Room 7 2nd floor Department of Periodontology Yenepoya Dental College Yenepoya University
Mangaluru
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448529518 |
| Fax |
|
| Email |
rksdental@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room 7 Department of Periodontology Yenepoya Dental College Yenepoya University
Dakshina Kannada, Mangalore , Karnataka |
|
|
Primary Sponsor
|
| Name |
Johnvee S |
| Address |
Yenepoya Dental College Deralakatte Mangalore Karnataka 575018 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Johnvee S |
Yenepoya dental college |
Room 7 2nd floor Department of Periodontology Yenepoya Dental College Yenepoya University
Mangaluru
Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9962198874
24286@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya ethics committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fixed orthodontic appliance
|
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.2% Chlorhexidine gluconate |
Mouthrinse containing 0.2% Chlorhexidine gluconate alone in plaque induced gingivitis patient with fixed orthodontic appliance |
| Intervention |
0.1% hyaluronic acid and 0.2% Chlorhexidine gluconate |
Efficacy of Mouthrinse containing 0.1% hyaluronic acid and 0.2% Chlorhexidine gluconate in plaque induced gingivitis patients with orthodontic appliance and check for the reduction in gingival inflammation score and also biomarker levels |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants with full-mouth fixed orthodontic appliance with plaque-induced gingivitis
Participants between age group of 18 years and above.
Presence of at least 24 natural teeth in the mouth excluding the third molars
Mild/moderate/severe gingivitis ( GI score by Loe & Silness 0.1-3.0)
Probing depth not more than 3 mm
|
|
| ExclusionCriteria |
| Details |
Physical or mental handicap.
Syndromic / systemic diseases contributing to inflammatory process.
Participants who had taken antibiotic therapy in the month prior to the commencement of the study.
Participants with known allergy to chlorhexidine or Hyaluronic acid.
Participants currently using mouthwashes
Smoking
Pregnant and lactating women.
Active caries.
Participants on anticoagulants
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in plaque score and gingival index score ( gingival inflammation) |
Assessed at baseline , 15 th day and at 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in inflammatory biomarker levels in both the groups |
Assessed at baseline and at 1 month from baseline |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
31/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Documentation in form excel by the principle investigator
- For how long will this data be available start date provided 01-08-2025 and end date provided 01-10-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
In the oral cavity, plaque forms biofilm over the tooth surface, that harbors numerous microorganism. The role of dental plaque at the interfaces of tooth and gingiva causes gingival inflammation, which could eventually lead to periodontitis. Orthodontics brackets are one of the plaque retentive factor which leads to gingivitis. Therapy for gingivitis is mainly directed at minimizing the etiologic factors to eliminate inflammation, thus allowing gingival tissues to heal. It can be managed with an effective plaque control program and debridement of tooth surfaces coupled with continued periodontal maintenance procedures to prevent re-initiation of inflammation. Chlorhexidine is one of the most effective topical antiseptics reported so far that has been used successfully for treating gingivitis and remains as gold standard for all chemical antiplaque agents. This study aims to assess the clinical and biochemical parameters to determine the efficacy of mouthrinse containing hyaluronic acid and Chlorhexidine gluconate in controlling plaque induced gingivitis in patients with fixed orthodontic appliance. HA has shown anti- inflammatory, anti-bacterial, and antioxidant effects in the treatment of periodontal diseases. Because of its biocompatibility and non-toxicity, the use of exogenous HA-based biomaterials, topically on to inflamed periodontal sites would provide beneficial effects in accelerating and modulating the host response |