| CTRI Number |
CTRI/2024/10/075101 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Does the use of Guduchi mouthwash and capsule gives better clinical result in the treatment of pyorrhea than scaling and root planing alone |
|
Scientific Title of Study
|
A comparative evaluation of efficacy of systemically and locally delivered Tinospora Cordifolia (Guduchi) as an adjunct to scaling and root planning in stage 2 to stage 4 periodontitis patient - A Randomised controlled clinical 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 Shubham Tale |
| Designation |
Postgraduate student |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
215 Department of Periodontology Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001
Boys Hostel Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001
Mumbai
MAHARASHTRA
400001
India |
| Phone |
919765671647 |
| Fax |
|
| Email |
taleshubham1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Gaikwad |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
215 Department of Periodontology Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001
Boys hostel Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9821098772 |
| Fax |
|
| Email |
perioraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Tale |
| Designation |
Postgraduate student |
| Affiliation |
Government Dental College and Hospital Mumbai |
| Address |
215 Department of Periodontology Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001
Boys hostel Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9765671647 |
| Fax |
|
| Email |
taleshubham1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Tale |
| Address |
215 Department of Periodontology Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001 |
| Type of Sponsor |
Other [Self Sponsered] |
|
|
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 Shubham Tale |
Government Dental College and Hospital Mumbai |
215 Department of Periodontology Government Dental College and Hospital st George Hospital compound pd mello road fort Mumbai Maharashtra city Mumbai-400001
Mumbai
MAHARASHTRA |
9765671647
taleshubham1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL,MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: DANTAVESHTAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tinospora cordifolia, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Antarabhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Corn starch will be filled in the gelatin capsules by using a manual capsule filling machine. |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Stage II to stage IV periodontitis (Greater than 3 mm of Clinical Attachment Loss) according to world workshop 2017 classification for periodontal and peri-implant diseases and conditions
Patients in age group of 21 - 60 years of either sex
Patients with at least 20 natural teeth
Patient ready to give written informed consent
|
|
| ExclusionCriteria |
| Details |
• Medically compromised patients,
• Patients on antibiotic or antimicrobial therapy in the past 6 months,
• Smokers and smokeless tobacco users,
• Patients who have received periodontal treatment in the past 6 months,
• 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
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| GINGIVAL INDEX, PLAQUE INDEX, PROBING POCKET DEPTH REDUCTION |
Baseline 1 week and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment loss |
1 week 1 month |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
15/11/2024 |
| 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)
|
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 - YES
- What data in particular will be shared?
Response (Others) - NA
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response (Others) - NA
- Who will be able to view these files?
Response (Others) - NA
- For what types of analyses will this data be available?
Response (Others) - NA
- By what mechanism will data be made available?
Response (Others) - NA
- For how long will this data be available start date provided 01-11-2024 and end date provided 17-10-2028?
Response (Others) - From the Date of Publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients having stage 2 to stage 4 periodontitis will be assigned randomly into 4 groups and will be given Tinospora cordifolia mouthwash, 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 patients will be assesed at 1 week and 1 month interval and measurement will be recorded for plaque index, gingival index, probing pocket depth, clinical attachment loss and then results will be drawn and published. |