| CTRI Number |
CTRI/2016/04/006895 [Registered on: 29/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
27/04/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of herbal
(ayurvedic) drugs and compare it with commonly used chlorhexidine in patients with chronic periodontitis |
|
Scientific Title of Study
|
Role of ayurvedic drugs in oral hygiene, maintenance and treatment |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Neelam Mittal |
| Designation |
Professor |
| Affiliation |
|
| Address |
Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
neelammittal@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Neelam Mittal |
| Designation |
Professor |
| Affiliation |
|
| Address |
Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
neelammittal@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Neelam Mittal |
| Designation |
Professor |
| Affiliation |
|
| Address |
Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
neelammittal@hotmail.com |
|
|
Source of Monetary or Material Support
|
| This research was funded by World Health Organization as GOI-WHO Collaborative Program (2010-2011) under the title “Role of Ayurvedic Drugs in Oral Hygiene, Maintenance and Treatmentâ€. |
|
|
Primary Sponsor
|
| Name |
WHO India |
| Address |
WHO Country Office
Rooms 533-537, A-wing
Nirman Bhawan
Maulana Azad Road
New Delhi - 110011 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institute of Medical Sciences |
Banaras Hindu University
Varanasi- 221005
Uttar Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Neelam Mittal |
Sir Sunderlal Hospital |
Room No. 208, Faculty of Dental Sciences, Sir Sundarlal Hospital, Banaras Hindu University
Varanasi
UTTAR PRADESH |
9415203360
neelammittal@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group I |
Only Scaling of teeth (control group) |
| Intervention |
Group II |
Scaling of teeth + use of 10 mL of 0.2% chlorhexidine mouthrinse for 1 minute for plaque control for 3 months |
| Intervention |
Group III |
Scaling of teeth + use of 0.5-2 grams of Khadiradi vati powder mixed in water in 3:1 ratio and applied twice daily on gums for plaque control for 3 months |
| Intervention |
Group IV |
Scaling of teeth + use of 0.5 – 2 grams Dashansanskar churan powder mixed in water in 3:1 ratio and applied twice daily on gums for plaque control for 3 months |
| Intervention |
Group V |
Scaling of teeth + use of 0.5-2 grams Neem powder mixed in water in 3:1 ratio and applied twice daily on gums for plaque control for 3 months |
| Intervention |
Group VI |
Scaling of teeth + use of 0.5-2 grams Apamarga powder mixed in water in 3:1 ratio and applied twice daily on gums for plaque control for 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 20 to 49 years suffering from mild to moderate chronic periodontitis |
|
| ExclusionCriteria |
| Details |
Immunocompromised patients, patients with grade III mobile teeth |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Community Periodontal Index for Treatment Needs (CPITN) scores |
3 months after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Community Periodontal Index for Treatment Needs (CPITN) scores |
1 month after intervention |
|
|
Target Sample Size
|
Total Sample Size="408"
Sample Size from India="408"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, outcome assessor blinded, parallel group multiple arm trial comparing effectiveness of chlorhexidine and four ayurvedic drugs in 408 patients with chronic periodontitis reporting in the OPD of Sir Sundarlal Hospital, Banaras Hindu University. The primary outcome measures decrease in CPITN scores after 3 months of intervention. The secondary outcome measures decrease in CPITN scores after 1 month of intervention. |