| CTRI Number |
CTRI/2026/01/101015 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Anti-plaque and anti-inflammatory effect of Cinnamomum tamala (Indian bay leaf) mouthrinse among patients with gum disease |
|
Scientific Title of Study
|
Evaluation of anti-plaque and anti-inflammatory effect of Cinnamomum tamala (Indian bay leaf) mouthrinse among gingivitis patients: A Randomized Controlled 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 |
Muthu Durga Lakshmi I |
| Designation |
Post Graduate |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Room no:2, 3rd floor, Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental Sciences, G.S.T Road,Chinnakolambakkam, Madhuranthagam T.K., Kancheepuram, Tamilnadu-603308, India.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9566341287 |
| Fax |
|
| Email |
mailmedrmdl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. MUTHU DURGA LAKSHMI I |
| Designation |
Post-Graduate |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Room no:2, 3rd floor, Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental Sciences, G.S.T Road,Chinnakolambakkam, Madhuranthagam T.K., Kancheepuram, Tamilnadu-603308, India.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9566341287 |
| Fax |
|
| Email |
mailmedrmdl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muthu Durga Lakshmi I |
| Designation |
Post Graduate |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Room no:2, 3rd floor, Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental Sciences, G.S.T Road,Chinnakolambakkam, Madhuranthagam T.K., Kancheepuram, Tamilnadu-603308, India.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9566341287 |
| Fax |
|
| Email |
mailmedrmdl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental sciences, G.S.T Road, Chinnakolambakkam, Madhuranthagam, Chengalpattu district, Tamilnadu-603308 |
|
|
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 MUTHU DURGA LAKSHMI I |
Karpaga Vinayaga Institute of Dental Sciences |
Room no:2, 3rd floor, Department of Public Health Dentistry, Karpaga Vinayaga Institute of Dental sciences, G.S.T Road, Chinnakolambakkam, Madhuranthagam, Chengalpattu district, Tamilnadu-603308
Kancheepuram
TAMIL NADU |
9566341287
mailmedrmdl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Gingivitis |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.2% of Chlorhexidine mouthrinse |
The gold standard of 0.2% of Chlorhexidine mouthrinse |
| Intervention |
Cinnamomum tamala (Indian bay leaf) mouthrinse |
The leaf material will be purchased. Cleaning will be done two times with running tap water and with distilled water so that all the dust and impurities runoff. At room temperature, leaves will be air-dried for a few hours. The weight of dry leaves will be taken and recorded. It will be then crushed by the mixer to get a fine powdered form and the weight of the powder will also be taken and recorded. One kg of freshly grounded Cinnamomum tamala leaves powder will be boiled in separate glass beakers, each containing 1 liter of distilled water, at 90°C for 20 minutes. After cooling, a mouthwash formulation of 60% of Cinnamomum tamala leaves then following additives, Tween 80 (10%), Peppermint oil (1%), Sodium benzoate (0.4%), Sodium saccharin (6%), and food coloring (0.2%), will be added.
In the formulation, Tween will be used as a solvent and suspending agent to homogenize the solution; Sodium benzoate will serve as a preservative because it can inhibit the growth of bacteria and fungi in acidic conditions; Saccharin will be used as a sweetener; Peppermint oil will be added to provide a distinctive aroma, and food coloring will be included as an additive to enhance attractiveness, maintain uniformity, stabilize the color, and prevent discoloration of the solution. The resulting solution will be homogeneous, clear, light brown in color, with a mint aroma and a sweet taste.
Quality assessment:
The quality assessment of Cinnamomum tamala (Indian bay leaf) mouthrinse will be checked at Karpaga Vinayaga Institute of Pharmaceutical Sciences |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age above 18-25 years with plaque |
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating women
2)Patients those who have oral lesions like oral ulcers, leukoplakia, candidiasis
3)Patients wearing an orthodontic appliance or removable partial denture
4)Patients with known systemic diseases like liver, cardiac and renal diseases, respiratory tract diseases, tonsillitis, stomach disorders
5)Patients with psychological or physical disabilities |
|
|
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 |
| Anti-plaque and anti-inflammatory effect of Cinnamomum tamala (Indian bay leaf) mouthrinse and Chlorhexidine mouthrinse by Modified Quigley Hein index and C-reactive inflammatory marker, respectively. |
At baseline and after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anti-inflammatory effect of Cinnamomum tamala (Indian bay leaf) mouthrinse and Chlorhexidine mouthrinse- C-reactive protein inflammatory marker |
At baseline and after 2 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/01/2026 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Participants of aged above 18 years recruited under the inclusion criteria, randomization will be done among the participants. Group A will receive scaling and 60% Cinnamomum tamala mouthrinse, Group B will receive scaling and Chlorhexidine mouthrinse for 2 weeks, and assess the modified Quigley Hein Index and C-Reactive Protein inflammatory marker at baseline and after 2 weeks |