| CTRI Number |
CTRI/2024/03/064678 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A COMPARATIVE EVALUATION OF EFFICACY OF SYSTEMICALLY AND LOCALLY DELIVERED BARLERIA PRIONITIS LINN (VAJRADANTI) AS AN ADJUNCT TO TOOTH CLEANING IN MODERATE TO SEVERE PYORREA PATIENTS. A RANDOMISED CONTROLLED CLINICAL TRIAL |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF EFFICACY OF SYSTEMICALLY AND LOCALLY DELIVERED
BARLERIA PRIONITIS LINN (VAJRADANTI) AS AN ADJUNCT TO SCALING AND ROOT PLANING IN
GENERALIZED MODERATE TO SEVERE CHRONIC PERIODONTITIS PATIENTS - A 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 |
Ajit Metkar |
| Designation |
3rd yr PG |
| Affiliation |
|
| Address |
215 department of periodontology, government dental college and hospital Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8329411395 |
| Fax |
|
| Email |
ajitmetkar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Gaikwad |
| Designation |
Professor and Head |
| Affiliation |
Government dental college and hospital,Mumbai |
| Address |
215 department of periodontology, government dental college and hospital Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9821098772 |
| Fax |
|
| Email |
perioraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajit Metkar |
| Designation |
3rd yr PG |
| Affiliation |
|
| Address |
215 department of periodontology
Government dental college hospital Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8329411395 |
| Fax |
|
| Email |
ajitmetkar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government dental college and hospital ,Mumbai |
|
|
Primary Sponsor
|
| Name |
Ajit Metkar |
| Address |
Government dental college hospital, Mumbai |
| 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 Rajesh Gaikwad Government dental college and hospital Mumbai |
215 department of periodontology Government dental college and hospital, Mumbai |
Government dental college and hospital, Mumbai 40001
Mumbai
MAHARASHTRA |
02222620668
deangdch_mumbai@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government dental college and hospital, Mumbail |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Generalized chronic periodontitis |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: BARLERIA PRIONITIS LINN (VAJRADANTI), Reference: NA, Route: Oral, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -), Additional Information: -(2) Medicine Name: BARLERIA PRIONITIS LINN (VAJRADANTI), Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo capsule | |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ï‚·Patients with generalized moderate to severe chronic periodontitis (Greater than 3 mm of Clinical Attachment Loss), according to 1999 International workshop for the classification of the periodontal diseases organized by the American Academy of Periodontology (AAP). (60)
ï‚·Patients in age group of 21 - 60 years of either sex,
ï‚·Patients with at least 20 natural teeth,
ï‚·Patient ready to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
ï‚·Medically compromised patients,
ï‚·Patients on antibiotic or antimicrobial therapy in the past 6 months,
ï‚·Smokers and smokeless tobacco users,
ï‚·Patients who have received periodontal treatment in the past 6 months,
ï‚·Pregnant women and lactating mothers,
Patients allergic to any material used in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque index gingival index |
1 week 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
probing pocket depth
clinical attachment level |
1 week 1 month |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/05/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Abstract: Periodontitis is initiated by the accumulation and maturation of pathogenic biofilm on the surface of teeth and oral mucosa. Ayurvedic drug such as Barleria prionitis linn (vajradanti) shows anti-inflammatory, anti-plaque action as an adjunct to scaling and root planing (SRP) in gingivitis, showed a significant reduction in plaque formation, gingival bleeding and pocket depth. This study aims to evaluate the therapeutic efficacy of Barleria Prionitis Linn (vajradanti) adjunct to scaling and root planing therapy in generalised moderate to severe chronic periodontitis patients. A Randomised Conrolled Clinical Trial was conducted on 96 patients will were randomly divided into 4 groups i.e. Group 1: placebo mouthwash and placebo capsule, Group 2: placebo mouthwash and Barleria prionitis linn capsule, Group 3: Barleria prionitis linn mouthwash + placebo capsule, Group 4: Barleria prionitis linn mouthwash and Barleria prionitis linn capsule. After scaling and root planing, the above drugs were prescribed to each group. Clinical periodontal parameters are recorded at baseline and 1 month. This study gives new direction, importance, and evaluation of significant pathways to treat periodontal diseases by ayurvedic drugs(Barleria prionitis linn). The required capsule and mouthwash will be provided by Sri Saptashrungi Ayurvedic College and Hospital, Nashik |