| CTRI Number |
CTRI/2025/02/080740 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Deep Cleaning with Placental Extract for Treating Gum Disease |
|
Scientific Title of Study
|
Evaluation of Scaling and Root Planing with Placental Extract as a Local Drug Delivery Agent in Chronic Periodontitis : A Split Mouth 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 Rakesh N Patel |
| Designation |
PG student |
| Affiliation |
Ahmedabad Dental College and Hospital |
| Address |
Department of periodontolody Division 7
Hare Krishna Mandir Road
Nr Science city
Bhadaj
Ahmedabad Gujarat India
Ahmadabad
GUJARAT
382115
India |
| Phone |
8128483454 |
| Fax |
|
| Email |
drrakeshjabvani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mishal Shah |
| Designation |
PROFESSOR |
| Affiliation |
Ahmedabad Dental College and Hospital |
| Address |
Department of periodontolody Division 7
Hare Krishna Mandir Road
Nr Science city
Bhadaj
Ahmedabad Gujarat India
Ahmadabad
GUJARAT
382115
India |
| Phone |
9909218929 |
| Fax |
|
| Email |
drmishalshah29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh N Patel |
| Designation |
PG student |
| Affiliation |
Ahmedabad Dental College and Hospital |
| Address |
Department of periodontolody Division 7
Hare Krishna Mandir Road
Nr Science city
Bhadaj
Ahmedabad Gujarat India
Ahmadabad
GUJARAT
382115
India |
| Phone |
8128483454 |
| Fax |
|
| Email |
drrakeshjabvani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Dental College and Hospital
Ahmedabad Gujarat India 382115 |
|
|
Primary Sponsor
|
| Name |
Dr Rakesh N Patel |
| Address |
Hare Krishnaa Mandir Road
Nr Science City
Bhadaj
Ahmedabad Gujarat
India 382115
|
| 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 Rakesh N Patel |
Ahmedabad Dental College and Hospital |
Department of periodontology
Hare Krishna Mandir Road
Nr Science city
Bhadaj
Ahmedabad Gujarat India
Ahmadabad
GUJARAT |
8128483454
drrakeshjabvani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Ahmedabad Dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Placental Extract gel |
Placental Extract gel as local drug delivery
Baseline
One month
Three month |
| Comparator Agent |
SRP |
Scaling and Root planing |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
localized Periodontal Pocket Depth of 4-6 mm |
|
| ExclusionCriteria |
| Details |
systemic diseases that impact periodontal health pregnant or lactating women
smokers
alcoholics and
tobacco consumers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gingival Index
Plaque Index
Probing pocket depth
Relative attachment level |
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival Index
Plaque Index
Probing pocket depth
Relative attachment level |
one months
three months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 4 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Chronic periodontitis involves progressive inflammation leading to the destruction of periodontal structures. Scaling and root planing (SRP) combined with adjunctive local drug delivery agents can enhance periodontal treatment outcomes. This study evaluated the efficacy of placental extract as a local drug delivery agent in conjunction with SRP for managing chronic periodontitis. |