| CTRI Number |
CTRI/2023/12/060526 [Registered on: 19/12/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Placement of local drug delivery Liquorice gel in subgingival pockets in chronic periodontitis patients |
|
Scientific Title of Study
|
Evaluation of the efficacy of Liquorice gel as an adjunct to non-surgical periodontal therapy in chronic periodontitis:A randomized control, clinico-microbial 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 |
Vaishnavi Sanjay Shah |
| Designation |
Post-graduate student |
| Affiliation |
Yogita Dental College and Hospital , Khed |
| Address |
Yogita Dental College and Hospital , Khed, Ratnagiri, Department of Periodontology(24)
Ratnagiri
MAHARASHTRA
415709
India |
| Phone |
9730120332 |
| Fax |
|
| Email |
drshahvaishnavi123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPrashanth Shetty |
| Designation |
Professor |
| Affiliation |
Yogita Dental College and Hospital , Khed |
| Address |
Yogita Dental College and Hospital , Khed, Ratnagiri, Department of Periodontology(24)
Ratnagiri
MAHARASHTRA
415709
India |
| Phone |
9886191999 |
| Fax |
|
| Email |
drprashanthshetty3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPrashanth Shetty |
| Designation |
Professor |
| Affiliation |
Yogita Dental College and Hospital , Khed |
| Address |
Yogita dental college and hospital , Khed , Ratnagiri, Department of Periodontology (24)
Ratnagiri
MAHARASHTRA
415709
India |
| Phone |
9886191999 |
| Fax |
|
| Email |
drprashanthshetty3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yogita Dental College and Hospital , Khed , Ratnagiri, Department of Periodontology (24) |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Shah |
| Address |
yogita dental college and hospital, khed , ratnagiri |
| Type of Sponsor |
Research institution |
|
|
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 Vaishnavi Shah |
Yogita Dental College and Hospital |
Yogita Dental College and Hospital, Khed , Ratnagiri, Department of Periodontology (24)
Ratnagiri
MAHARASHTRA |
9730120332
drshahvaishnavi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YOGITA DENTAL COLLEGE INSTITUTIONAL ETHICAL COMMITTE |
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 |
| Intervention |
Liquorice gel |
The study spans for 3months in which the the intervention agent Liquorice gel application will be done only once after scaling and root planing in the whole study span. |
| Comparator Agent |
Scaling and root planing |
The study span for 3 months in which the standard protocol for periodontitis patients that is scaling and root planing will be done at baseline . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.A minimum of 20 natural teeth present
3.Healthy patients diagnosed with chronic periodontitis.
4. Patients having pocket probing depth of 4-6 mm.
|
|
| ExclusionCriteria |
| Details |
1.Tobacco-smokers, electronic cigarette users, smokeless tobacco product users, alcohol users.
2.Individuals that had used antibiotics, probiotics, non-steroidal anti-inflammatory drugs and/or steroids within the past 3-month.
3.Individuals with systemic diseases (such as cardiovascular diseases,diabetes,, renal disorders, hepatic disorders and/or acquired immune deficiency syndrome/HIV.)
4.Lactating and/or pregnant females.
5.Third molars and fractured teeth with embedded root remnants.
6.Completely edentulous individuals.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment loss, Probing Depth, Microbial count |
Baseline , 1 month , 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index , Sulcus Bleeding Index |
Baseline , 1 month , 3 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/01/2024 |
| 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="6"
Days="30" |
|
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
|
THE STUDY WILL BE CONDUCTED TO COMPARE THE EFFICECY OF PREPARED LIQUORICE GEL IN CHRONIC PERIODONTITIS PATIENTS WITH SHALLOW POCKET DEPTH OF 4-6 mm ADJUNCT TO SCALING AND ROOT PLANING WIYH ONLY SCALING AND ROOT PLANING. Total sample size is 30 , 15 in each group(test group and control group) . The study span is of 3 months. At baseline a detailed intra -oral recordings and complete scaling and root planing will be done in test group and in control group local drug Liquorice gel will be delivered in th subgingival pockets after scaling and root planing.Microbial samples will be taken to evaluate the anaerobic organisms count. At 1 month recall period clinical records and microbial samples will be taken. At 2month recall period clinical records and microbial samples will be taken.
Microbial organisms P.gingivalis,A.actinomycecomitans,F.nucleatum amd P.intermedia will assessed to check the efficacy of Liquorice gel as these are the main pathogenic organisms of periodontitis.
At the end of the study a between the test group and control group will be evaluated to check the efficacy of Liquorice gel as local drug delivery.
|