| CTRI Number |
CTRI/2024/05/067879 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
03/05/2024 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation Between Chlorhexidine Gel And Herbal Gel for Periodontal Treatment |
|
Scientific Title of Study
|
A Comparative Evaluation for the efficacy of Chlorhexidine Gel And
Khadir (Acacia catechu) Gel as an adjunct to Scaling & Root Planing, in Chronic Periodontitis cases: A 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 Unnati Shirbhate |
| Designation |
Postgraduate Student |
| Affiliation |
Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Periodontics, Number 3 Department, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020106697 |
| Fax |
|
| Email |
unnatishirbhate0791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Bajaj |
| Designation |
Associate Professor |
| Affiliation |
Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Periodontics, Number 3 Department, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020106696 |
| Fax |
|
| Email |
pavbajaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavan Bajaj |
| Designation |
Associate Professor |
| Affiliation |
Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Periodontics, Number 3 Department, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi.
Wardha
MAHARASHTRA
442001
India |
| Phone |
8412045019 |
| Fax |
|
| Email |
pavbajaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India, 442001. |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Unnati Shirbhate |
Sharad Pawar Dental College |
Department of periodontics, 3 number dept., Sharad pawar dental college, Datta meghe institute of higher education and research
Wardha
MAHARASHTRA |
7020106697
unnatishirbhate0791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Datta meghe institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine gel |
1% Chlorhexidine gel is used after scaling and root planing as local drug delivery once in periodontitis patient and assessed after 3 months |
| Intervention |
Herbal gel |
1% Herbal gel is used after scaling and root planing as local drug delivery once in periodontitis patient and assessed after 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Both male and female patients of age group 30-50 years.
2) Presence of minimum 15 teeth.
3) Motivated to have therapy and willing to complete the follow up.
4) Patient suffering from chronic periodontitis having at least 2 pockets of more than 4 millimetre.
5) Subjects who readily give informed consent for the study. |
|
| ExclusionCriteria |
| Details |
1) Immuno-compromised and systemic unhealthy patients.
2) Pregnant or lactating mothers.
3) Patient with known sensitivity with chlorhexidine.
4) Patients who have undergone periodontal therapy in the last 6 months.
5) Patients with any systemic disorder affecting periodontal health.
6) Patients with infectious conditions other than periodontitis.
7) Regular users of mouthwash.
8) Patients consuming tobacco in any form, smokers, alcoholics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Herbal gel in comparison with chlorhexidine gel is effective in chronic periodontitis patients at baseline and 3 months |
Herbal gel in comparison with chlorhexidine gel is effective in chronic periodontitis patients at baseline and 3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2024 |
| 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 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
|
This study is undertaken to evaluate the effectiveness of chlorhexidine gel and Herbal gel as an adjunct to scaling and root planing in patients with chronic periodontitis where we will take 25 patients in Chlorhexidine group and 25 patients in Herbal gel as local drug delivery. |