| CTRI Number |
CTRI/2019/03/017924 [Registered on: 06/03/2019] Trial Registered Prospectively |
| Last Modified On: |
19/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison og Triphala Gel and Chlorhehidine Gel as Local Drug Delivery Agent in Chronic Periodontitis Patients |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of the Efficacy of Triphala Gel and Chlorhexidine Gel as Local Drug Delivery Agent and their Effect on Salivary Matrix Metalloproteinases-8 Levels in Chronic Periodontitis Patients. A Randomized Control Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arpeet Atmaram Krantikar |
| Designation |
1st Year MDS Student In Dept. of Periodontics |
| Affiliation |
NAir Hospital Dental College, Mumbao-08 |
| Address |
2nd Floor, Dept of Periodntics,
Nair Hospital Dental College,
Mumbai-08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9011921093 |
| Fax |
|
| Email |
arpeetkrantikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praneeta Kamble |
| Designation |
Associate Professor and Guide In Dept. of Periodontics |
| Affiliation |
NAir Hospital Dental College, Mumbao-08 |
| Address |
2nd Floor, Dept of Periodntics,
Nair Hospital Dental College,
Mumbai-08
2nd Floor, Dept of Periodntics,
Nair Hospital Dental College,
Mumbai-08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9820263468 |
| Fax |
|
| Email |
drpraneetakamble@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arpeet Atmaram Krantikar |
| Designation |
1st Year MDS Student In Dept. of Periodontics |
| Affiliation |
NAir Hospital Dental College, Mumbao-08 |
| Address |
2nd Floor, Dept of Periodntics,
Nair Hospital Dental College,
Mumbai-08
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9011921093 |
| Fax |
|
| Email |
arpeetkrantikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Arpeet Krantikar
F1105 Sukhajarta Housing Society,
Curry Road, Mumbai |
|
|
Primary Sponsor
|
| Name |
Arpeet Krantikar |
| Address |
F-1105 Sukhakarta housing society, Curry Road, Mumbai |
| Type of Sponsor |
Other [Pg Student] |
|
|
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 Arpeet Krantikar |
Nair Hospital Dental College |
2nd Floor, Dept of Periodontics,
Nair Hospital Dental College,
Mumbai-08
Mumbai
MAHARASHTRA |
9011951093
arpeetkranikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Nair Hospital Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine |
Chlorhexidine in gel form at 0.2% concentration
1-2 ml in gingival sulcus
Only one application
|
| Intervention |
Triphala Gel |
Triphala in gel form at the concentration of 0.6%
1-2 ml in Gingival Sulcus
Only one application |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in good systemic health
2.The patients ranged in age from 20 to 60 years
3.Patients with chronic periodontitis with isolated periodontal pockets. (probing pocket depths [PPDs] ≥5 mm)
4.Patients with a minimum of 10 teeth in their total dentition
5.Cooperative patients who can be motivated to maintain good oral hygiene.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who did not give consent.
2.Subjects using antibiotic medications, mouthwashes, chewing gums, tobacco at the time of the study or 6months prior to it.
3.Patients with known hypersensitivity to Chlorhexidine.
4.Patients with furcation involvement;
5.Subjects having any oral or systemic disease.
6.Pregnant and/or lactating mothers.
7.Patients with any bleeding disorders or on anticoagulant therapy.
8.Patients who had received any type of periodontal therapy for the past 6 months
9.Patients who were smokers or had tobacco in any other form.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Plaque Index (P.I.)(TURSKEY-GILMORE-GLICKMAN MODIFICATION OF QUIGLEY HEIN).
2.Gingival Index (G.I.) (LOE &SILNESS, 1963).
3.Probing Pocket Depth (PPD).
4.Clinical Attachment Level (CAL).
|
Outcomes assesed at Baseline, 1 month after Scaling and Root Planing and 3 months after application of LDD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary Matrix Metalloproteinases-8 Levels by using ELISA |
Outcome assessed at baseline, 1 month after Scaling and Root planing and 3 months after LDD placement |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2019 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to evaluate and compare clinically
the effect of Triphala gel and Chlorhexidine gel as Local Drug Delivery agent
and its effect on Salivary Matrix Metalloproteinases-8 levels. A total of
40npatients with chronic periodontitis will be selected from OPD of Dept. of
Periodontics, Nair Hospital Dental College, Mumbai and will be equally divided
in two groups of which one will receive Triphala gel as LDD and Chlorhexidine
gel as LDD and 20 periodontally healthy patients will be selected on which only
Salivary MMP-8 estimation will be done. The study is clinical interventional prospective study.
Computer generated randomization will be done. The study duration will be of 18
months of which 4 months for patient’s follow-up and 14 months for completion
of project. The efficacy parameters are plaque index, gingival index, probing
pocket depth, clinical attachment levels and salivary MMP-8 levels will be
recorded at baseline in periodontally healthy group and at baseline, 1 month and
3 months post surgery in other two groups. The data will be analyzed individually
for all the patients. The statistical analysis method to be used will be
Repeated measure ANOVA followed by post-hoc test. There is no conflict of
interest.
|