| CTRI Number |
CTRI/2025/01/079505 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparision of efficacy of an herbal extract mouthrinse with chlorhexidine gluconate mouth rinse in patients with mild periodontitis |
|
Scientific Title of Study
|
comparision of efficacy of punica granatum and citrus paradisi herbal extract mouthrinse with chlorhexidine gluconate mouth rinse in treatment of stage 1 periodontitis:a clinical and 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 |
DrHarshithaC |
| Designation |
post graduate |
| Affiliation |
JSS DENTAL COLLEGE AND HOSPITAL |
| Address |
Department Of Periodontology , JSS Dental College and Hospital , JSS Academy of Higher Education And Research ,Mysuru
Mysore
KARNATAKA
570015
India |
| Phone |
6366406555 |
| Fax |
|
| Email |
harsh25channappa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr pratibha shashikumar |
| Designation |
Reader |
| Affiliation |
JSS DENTAL COLLEGE AND HOSPITAL |
| Address |
Department of Periodontology , JSS Dental College and Hospital , JSS Academy of Higher Education and Research, Mysuru.
Mysore
KARNATAKA
570015
India |
| Phone |
9986544409 |
| Fax |
|
| Email |
drpratibhavg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHarshithaC |
| Designation |
post graduate |
| Affiliation |
JSS DENTAL COLLEGE AND HOSPITAL |
| Address |
Department Of Periodontology , JSS Dental College and Hospital , JSS Academy of Higher Education And Research ,Mysuru.
Mysore
KARNATAKA
570015
India |
| Phone |
6366406555 |
| Fax |
|
| Email |
harsh25channappa@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSSAHER , JSS DENTAL COLLEGE AND HOSPITAL , MYSURU 570015 |
|
|
Primary Sponsor
|
| Name |
Dr Harshitha C |
| Address |
Department of Periodontology , JSS Dental College and Hospital ,JSS Academy of Higher Education and Research ,Mysuru 570015. |
| Type of Sponsor |
Other [Self] |
|
|
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 HARSHITHA |
JSS DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PERIODONTOLOGY JSS DENTAL COLLEGE AND HOSPITAL
SRI SHIVARATHEESHWARA NAGAR
BANNIMANTAP ,MYSURU 570015
Mysore
KARNATAKA |
6366406555
harsh25channappa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jss dental college and hospital institutional ethics committee |
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 mouth rinse |
scaling and root planning followed by administration with mouth rinses with route of administration being orally , to be used twice daily after brushing for 30 day. |
| Comparator Agent |
Punica Granatum AND citrus Paradisi Mouth Rinse |
scaling and root planing followed by administration with mouth rinses with route of administration being orally , to be used twice daily after brushing for 30 days . |
| Intervention |
scaling and root planning |
scaling and root planning done only at baseline . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.age:18-55 years
2. presenceof atleast 20 natural teeth
3. plaque and gingival index more than or equal to 1.5
4. probing depth not more than 4mm |
|
| ExclusionCriteria |
| Details |
h/o periodontal treatment in last 6 months
h/o antibiotic and anti inflammtory usage during 6 months
h/o of known systemic disease that would alter the healing response of oraltissue
smokers smoking or use of tobacoo in any form
pregnant anf lactating women |
|
|
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 |
| To compare the efficacy of punica granatum and citrus paradisi herbal extract mouth rinse with chlorhexidine gluconate mouth rinse in stage one periodontitis |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses the salivary Interleukin 1 beta levels |
30 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Mouthwashes containing plant extracts which have no adverse effects are being used for their antiplaque and anti-inflammatory properties in the treatment of chronic gingivitis. Hence an attempt is being made to test and compare the efficacy of a combination herbal mouthwash with commercially available chlorhexidine mouthwash.Material: The formulation will be procured from Group Pharmaceuticals Pvt Lmt. Bengaluru. Biochemical analysis of saliva will be done is department of Biochemistry, JSS Medical College, Mysuru. Study Design: This is a single blind clinical and biochemical study to compare the efficacy of a combination of punica granatum and citrus paradisi herbal mouth rinse with a currently marketed chlorhexidine mouth rinse in patients with stage 1 periodontitis.Method: Subjects who fulfil the inclusion criteria will be included in the study and will be randomly allocated to three treatment groups after scaling and oral hygiene instructions Group A: Herbal Mouth Rinse containing punica granatum and citrus paradisi. Group B: 0.2 % Chlorhexidine Mouth rinse. Group C: Scaling and root planing. Clinical parameters to be recorded are: Clinical parameters will be evaluated at the baseline, 15th and 30th day by a single calibrated examiner. · Plaque index (Silness and Loe,1964) · Sulcus bleeding index (Muhlemann-son) · Probing Pocket Depth · Clinical Attachment Level The saliva samples will be collected at baseline and 30 days using a sterile Eppendorf tube and will be sent for biochemical analysis which will include measuring the total interleukin 1 β level in the sample. |