| CTRI Number |
CTRI/2025/05/086667 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of a gel of T. Arjuna bark placed in gums of patients with gum disease. |
|
Scientific Title of Study
|
Comparative Evaluation Of The Efficacy Of Sub
Gingivally Delivered T. Arjuna Bark Gel As An Adjunct To
Scaling And Root Planing Versus Scaling And Root
Planing Alone In Individuals With Periodontitis – A
Randomized Controlled 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 |
DR DIPIKA MITRA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Terna Dental College |
| Address |
Department 101, department of periodontology, Plot no.12, Terna Campus Rd, opp. nerul west Railway station, Sector 22,Nerul,Navi Mumbai Mumbai MAHARASHTRA 400706 India
Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9820180406 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DIPIKA MITRA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Terna Dental College |
| Address |
Department 101, department of periodontology, Plot no.12, Terna Campus Rd, opp. nerul west Railway station, Sector 22,Nerul,Navi Mumbai Mumbai MAHARASHTRA 400706 India
Thane
MAHARASHTRA
400706
India |
| Phone |
9820180406 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GIRISH TAMHANE |
| Designation |
PG STUDENT |
| Affiliation |
Terna Dental College |
| Address |
101, 1ST FLOOR, DEPARTMENT OF PERIODONTOLOGY, TERNA DENTAL COLLEGE, NERUL,NAVI MUMBAI
Thane
MAHARASHTRA
400706
India |
| Phone |
7021581096 |
| Fax |
|
| Email |
drgirishtamhane@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PERIODONTOLOGY, TERNA DENTAL COLLEGE, NERUL, NAVI MUMBAI, MAHARASHTRA ,INDIA PIN CODE 400706 |
|
|
Primary Sponsor
|
| Name |
TPCTs Terna Dental college |
| Address |
TPCTs Terna Dental college
Address Plot no. 12, Campus Rd,Opp. Nerul west Railway station , Sector 22,
Nerul west, Sector 22, Nerul, Navi Mumbai Mumbai
MAHARASHTRA 400706 India
|
| Type of Sponsor |
Other [Private Dental college] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girish Tamhane |
Terna Dental College |
Department of Periodontology, 101, 1st floor.
Thane
MAHARASHTRA |
7021581096
drgirishtamhane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental college Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
CHRONIC PERIODONTITIS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
T. ARJUNA BARK GEL |
All patients of periodontitis with 4- 6 mm pocket depth will be treated with scaling and root planing followed by subgingival delivery of T. ARJUNA BARK GEL.Baseline evaluation will
be done for plaque index,
gingival index, probing pocket depth,
relative attachment loss. Patient will be recalled after 1 monthand 3 month for the evaluation of same parameters. |
| Comparator Agent |
Scaling and root planing |
All patients of periodontitis with 4- 6 mm pocket depth will be treated with scaling and root planing .Baseline evaluation will be done for plaque index, gingival index, probing pocket depth, relative attachment loss. Patient will be recalled after 1 monthand 3 month for the evaluation of same parameters. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
.Both male and female patients with 4mm - 6mm pocket depth in at least 2 teeth in contralateral quadrants.2.Age group between
18-60 years with good systemic health.3. Minimum 20 teeth should
be present in the mouth of patients. 4.Patients with no history of
allergies |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from any known systemic
diseases.2.Smokers and alcoholic patients.3 Pregnancy or lactating
female patients.4.Patients who have received surgical or nonsurgical
periodontal therapy in last 3 months prior to the baseline visit |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the clinical efficacy of sub-gingivally
delivered T. Arjuna bark gel as an adjunct to non-surgical periodontal therapy in patients with periodontitis having 4mm - 6mm pocket depth: a split mouth randomized study
randomised controlled trial. |
Baseline
One month after local drug delivery
Three month after local drug delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate improvement in plaque index,
gingival index,probing
pocket depth and relative attachment loss |
Baseline
One month after local drug delivery
Three month after local drug delivery |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
16/10/2025 |
| 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="4"
Days="0" |
|
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 clinical split mouth study to evaluate the clinical efficacy of sub gingivally T. Arjuna bark gel as an adjunct to scaling and root planing in patients with periodontitis. Study desig :Randomized Split mouth study .Group 1 consisting of 25 subjects with periodontitis, having 4mm- 6mm pocket depth receiving T. Arjuna bark gel as a local drug delivery and Group 2 consisting of 25 subjects with periodontitis having 4mm- 6mm pocket depth undergoing only scaling and root planing. The clinical parameters [ plaque index, gingival index, relative attachment loss, probing pocket depth] will be evaluated at baseline, one month and three month period. The data obtained will be entered in Microsoft excel spread sheet and will be further analyzed with the help of SPSS software ( version 17.0, IBM.USA) |