| CTRI Number |
CTRI/2026/04/108383 [Registered on: 15/04/2026] Trial Registered Prospectively |
| Last Modified On: |
15/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Bakul Bark Extract (Used Locally vs. Orally) for Treating Severe Gum Disease |
|
Scientific Title of Study
|
Comparative Evaluation of the Efficacy of Systemically and Locally Administered Bakul (mimusops elengi) bark Extracts as an Adjunct to Scaling and Root Planing in Generalized Moderate to Severe Chronic Periodontitis:A Randomized Double-Blind Placebo-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 |
Dr Thenmozhi B R |
| Designation |
MDS PURSUING |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL GHATI CAMPUS AURANGABAD |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
GHATI CAMPUS
AURANGABAD
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
GHATI CAMPUS
AURANGABAD
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7339187345 |
| Fax |
|
| Email |
thenmozhi86dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR C D DHALKARI |
| Designation |
professor and HOD |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL GHATI CAMPUS AURANGABAD |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
GHATI CAMPUS
AURANGABAD
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
GHATI CAMPUS
AURANGABAD
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
|
| Fax |
|
| Email |
cddhalkari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR THENMOZHI B R |
| Designation |
MDS PURSUING |
| Affiliation |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL GHATI CAMPUS AURANGABAD |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
GHATI CAMPUS
AURANGABAD
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
GHATI CAMPUS
AURANGABAD
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
7339187345 |
| Fax |
|
| Email |
thenmozhi86dr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR THENMOZHI B R |
| Address |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL
GHATI CAMPUS,Naralibagh,chh.sambhajinagar-431001
AURANGABAD |
| 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 |
| Thenmozhi B R |
Government dental college and hospital |
dept no;154,1st floor,Ghati campus, chh.sambhajinagar
Aurangabad
MAHARASHTRA |
7339187345
thenmozhi86dr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| iec |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: tinospora cordifolia, Reference: na, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: placebo | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: bakul(mimusops elengi), Reference: bhavprakash nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: bakul mouthwash, Reference: bhavprakash nigantu, Route: Topical, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: bakul , Reference: bhavprakash nigantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -mouthwash and capsules |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 30-65 years with generalized moderate to severe chronic periodontitis.
2. Patients with at least 20 natural teeth.
3. Patients willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Systemically compromised patients, including those with uncontrolled systemic conditions.
2. Patients receiving ongoing antibiotic or antimicrobial
therapy.
3. Smokers or users of smokeless tobacco.
4. Individuals who have received periodontal therapy in the last 6 months.
5. Pregnant or lactating women.
6. Allergy to the material.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Modified Gingival Index (MGI) by Lobene et al., 1986 (baseline, 7 days, 1 month)
• Papillary Bleeding Index (PBI) by Saxer and Muhlemann, 1975
• Plaque Index (PI) by Silness and Loe, 1964 (baseline, 7 days, 1 month)
• Pocket Probing Depth (PPD) (baseline, 1 month)
• Clinical Attachment Loss (CAL) (baseline, 1 month)
• Radiographic Evaluation of Bone Level (baseline, 1 month
|
• Modified Gingival Index (MGI) by Lobene et al., 1986 (baseline, 7 days, 1 month)
• Papillary Bleeding Index (PBI) by Saxer and Muhlemann, 1975
• Plaque Index (PI) by Silness and Loe, 1964 (baseline, 7 days, 1 month)
• Pocket Probing Depth (PPD) (baseline, 1 month)
• Clinical Attachment Loss (CAL) (baseline, 1 month)
• Radiographic Evaluation of Bone Level (baseline, 1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 |
|
Date of First Enrollment (India)
|
30/04/2026 |
| 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="1"
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
|
Patients having moderate to severe chronic periodontitis will be assigned randomly into 4 groups and will be given mimusops elengi mouthwash, capsules and placebo mouthwash according to the groups. Baseline records will be taken and scaling and root planing will be performed. Upon completion of scaling and root planing patient will be given above mentioned interventions according to their groups. then patient will be assessed at 1 week and 1 month interval and measurement will be recorded for plaque index, modified gingival index, papillary bleeding index, probing pocket depth, clinical attachment loss and then results will be drawn and published |