| CTRI Number |
CTRI/2025/04/085854 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Helping gums heal: comparing two mouthwashes for treating plaque-induced gum inflammation
|
|
Scientific Title of Study
|
Evaluation of plaque control efficacy of chlorhexidine plus hyaluronic acid mouthrinse compared to chlorhexidine mouthrinse: a double blinded randomised controlled clinical 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 |
Deblina Saha |
| Designation |
Post Graduate Trainee |
| Affiliation |
Kalinga Institute Of Dental Sciences |
| Address |
Department of Periodontology and Oral Implantology, Kalinga Institute of Dental Sciences, KIIT (Deemed to be university), KIIT Campus, Patia, Bhubaneswar
Koel Campus, Sishu Bihar, Bhubaneswar-751024
Khordha
ORISSA
751024
India |
| Phone |
9606316889 |
| Fax |
|
| Email |
deblinasaha02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srishty Goyal |
| Designation |
MDS-Periodontology |
| Affiliation |
Kalinga Institute Of Dental Sciences |
| Address |
Department of Periodontology and Oral Implantology, Kalinga Institute of Dental Sciences, KIIT (Deemed to be university), KIIT Campus, Patia, Bhubaneswar
Koel Campus, Sishu Bihar, Bhubaneswar-751024
Khordha
ORISSA
751024
India |
| Phone |
7060128287 |
| Fax |
|
| Email |
srishtygoyal575@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishty Goyal |
| Designation |
MDS-Periodontology |
| Affiliation |
Kalinga Institute Of Dental Sciences |
| Address |
Department of Periodontology and Oral Implantology, Kalinga Institute of Dental Sciences, KIIT (Deemed to be university), KIIT Campus, Patia, Bhubaneswar
Koel Campus, Sishu Bihar, Bhubaneswar-751024
Khordha
ORISSA
751024
India |
| Phone |
7060128287 |
| Fax |
|
| Email |
srishtygoyal575@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics and Oral Implantology, Room no. 4, 1st floor,Kalinga Institute of Dental Sciences, Bhubaneswar, Odisha, India, PIN-751024 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Srishty Goyal |
Kalinga Institute of dental sciences |
Department of Periodontics and Oral Implantology, Room No. 04, First floor,Bhubaneswar-751024
Khordha
ORISSA |
7060128287
srishtygoyal575@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K050||Acute gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthrinse |
use of 10ml undiluted solution twice daily for 4 weeks |
| Intervention |
chlorhexidine plus hyaluronic acid mouthrinse |
use of 10ml undiluted solution twice daily for 4 weeks |
| Comparator Agent |
Saline Placebo Mouthrinse |
use of 10 ml undiluted solution twice daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-22 years
Systemically healthy
Have more than 20 natural teeth.
Diagnosis of biofilm-induced gingivitis of an intact periodontium.
Absence of supra- or subgingival calculus detected visually or by using a periodontal probe, and perform regular tooth brushing.
|
|
| ExclusionCriteria |
| Details |
Current use of any type of mouthwash.
Smoking habit, presence of active caries.
Ongoing orthodontic treatment (including post-treatment retainers).
Periodontal treatment within the past 6 months and a diagnosis of periodontitis.
Use of antibiotics within the past 4 months or requirement for antibiotic prophylaxis.
Systemic or topical nonsteroidal anti-inflammatory drug treatment for the past 4 months.
Pregnancy or lactation, history of heart valve replacement, and known intolerance or allergy to mouth rinses.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Plaque index, Gingival Index, Gingival Bleeding Index |
baseline, 2 weeks, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
10/05/2025 |
| 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="2"
Days="15" |
|
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
|
This is a randomized , parallel group, active controlled,double blinded interventional clinical trial that compares effectiveness of Chlorhexidine vs Chlorhexidine plus hyaluronic acid in the management of biofilm induced gingivitis patients. Also efficacy of both the mouthwashes will be compared with placebo saline mouthwash. Recruitment of 36 participants will start from 10th May, 2025 according to the inclusion and exclusion criteria and after that participants will be randomized using computer based randomization, allocation concealment will be done using opaque envelop method. This study is a single site clinical trial where patients are selected and evaluated in the Department of Periodontology , Kalinga Institute of dental sciences, Bhubaneswar. This is self funded and primary outcome of the study is reduction in clinical parameters such as PI,GI,GBI at 2 weeks and 4 weeks.
|