| CTRI Number |
CTRI/2024/05/067674 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assess the effect of Liquorice gel as local drug delivery agent for treatment of Chronic Periodontitis |
|
Scientific Title of Study
|
Assessment of the efficacy of subgingivally delivered Liquorice gel on clinical parameters and Prostaglandin E2 level in Chronic Periodontitis : A Clinico-Biochemical 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. Diksha Gupta |
| Designation |
Junior Resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Room No.427, Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UP University of Medical Sciences, Saifai, Etawah
Room No.427, Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UP University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09899073339 |
| Fax |
|
| Email |
dikshagupta1504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bipin Kumar Yadav |
| Designation |
Professor |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Room No.415, Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UP University of Medical Sciences, Saifai, Etawah
Room No.415, Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UP University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8449619482 |
| Fax |
|
| Email |
drbipinkumaryadavperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Diksha Gupta |
| Designation |
Junior Resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Room No.427, Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UP University of Medical Sciences, Saifai, Etawah
Room No.427, Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UP University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09899073339 |
| Fax |
|
| Email |
dikshagupta1504@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Diksha Gupta
Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UP University of Medical Sciences, Saifai, Etawah-206130, India |
|
|
Primary Sponsor
|
| Name |
Dr Diksha Gupta |
| Address |
Room No.427, Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UP University of Medical Sciences, Saifai, Etawah-206130, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Diksha Gupta |
Uttar Pradesh University of Medical Sciences |
Room No.427, Department of Periodontology, Faculty of Dental Sciences, 4th Floor, Old building, UPUMS, Saifai, Etawah
Etawah
UTTAR PRADESH |
9899073339
dikshagupta1504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Uttar Pradesh University of Medical Sciences Ethical Committee |
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 |
Agent- Lab prepared 0.1% concentrated liquorice gel in polymeric base with added preservatives.
Agent-Lab prepared polymeric base gel with preservatives.
Dose-Depends upon the probing pocket depth.
Frequency-The gel is delivered using 30-gauge needle and syringe in the gingival sulcus once only after the completion of full mouth scaling and root planing.
Route of administration-Local Drug Delivery
Total Duration-30 days
|
| Comparator Agent |
Placebo gel |
Agent-Lab prepared polymeric base gel with preservatives.
Dose-Depends upon the probing pocket depth.
Frequency-The gel is delivered using 30-gauge needle and syringe in the gingival sulcus once only after the completion of full mouth scaling and root planing.
Route of administration-Local Drug Delivery
Total Duration-30 days
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with moderate chronic periodontitis with bilateral nearly symmetrical
sites having pocket depth of ≥4mm but ≤6mm.
2. Systemically healthy patients. |
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients.
2. Smokers.
3. Pregnant or lactating women.
4. Patients who had undergone periodontal therapy or used antibiotics/
analgesics/ anti-inflammatory drugs in the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Plaque index (PI), Gingival index (GI), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL) and PGE2 levels in GCF |
Baseline (Before SRP & gel placement)
After 15 days of gel placement
After 30 days of gel placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Plaque index (PI) and Gingival index (GI) |
Baseline (Before SRP & gel placement)
After 15 days of gel placement
After 30 days of gel placement |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
29/05/2024 |
| 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)
|
Open to Recruitment |
| 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
|
AIM: To evaluate the efficacy of subgingivally delivered Liquorice gel on clinical parameters and prostaglandin E2 levels in Chronic Periodontitis.
Research Hypothesis: To know about the effect of herbal agent i.e. Liquorice as a local drug delivery agent for the management of chronic periodontitis. |