| CTRI Number |
CTRI/2025/08/092469 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Academic trial (2 biomaterials)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess two materials [1.enamel-based gel(synthetic), 2.platelet-rich injection (derived from 10ml of patients blood)] in the treatment of gum infections in patients with gum disease |
|
Scientific Title of Study
|
Comparison Of Enamel Matrix Derivative and Injectable Platelet Rich Fibrin as
an adjunct to Non-Surgical Periodontal Therapy: A Randomized Control 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 |
Dr Madhumitha S |
| Designation |
First year postgraduate, Department of Periodontology |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry |
| Address |
Department of Periodontology, 3A, 3rd floor, new building, Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry Cuddalore EC Road, Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
6374197114 |
| Fax |
|
| Email |
madhumithacud28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratebha B |
| Designation |
Guide, Professor, Department of Periodontology |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry |
| Address |
Department of Periodontology,3A, 3rd floor, new building, Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry Cuddalore EC Road, Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894360543 |
| Fax |
|
| Email |
pratebhabalu@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saravana Kumar R |
| Designation |
Professor, Head of the department, Department of Periodontology |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry |
| Address |
Department of Periodontology,3A,3rd floor, new building, Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry Cuddalore EC Road, Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9840887003 |
| Fax |
|
| Email |
saravanakumarr@igids.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, 3A, 3rd floor, new building, Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry Cuddalore EC Road, Pillayarkuppam, Puducherry- 607402, India |
|
|
Primary Sponsor
|
| Name |
Dr Madhumitha S |
| Address |
Department of Periodontology, 3A, 3rd floor, new building, Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry Cuddalore EC Road, Pillayarkuppam, Pondicherry Cuddalore EC Road, Pillayarkuppam, Pondicherry- 607402, 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 Madhumitha S |
Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth |
Department of Periodontology, 3A, 3rd floor, new building, Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry Cuddalore EC Road, Pillayarkuppam, Puducherry
Pondicherry
PONDICHERRY |
6374197114
madhumithacud28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Institute of Dental Sciences, SBV, Pondicherry |
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 |
Enamel matrix derivative (Struamann Emdogain®) |
Scaling and root planing with Struamann Emdogain®
1.5 ml- single injection, through gingival sulcus, for a duration of 60 seconds.
|
| Intervention |
Injectable Platelet rich fibrin |
Scaling and root planing with Injectable platelet rich fibrin
1.5ml- single injection, through gingival sulcus, for a duration of 60 seconds. |
| Comparator Agent |
Without adjuncts |
Scaling and rot planing |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Stage II/III periodontitis- CAL of 5-8 mm with PPD of 5-8 mm,
Interdental vertical defects detected by radiovisiographs.
|
|
| ExclusionCriteria |
| Details |
Patients who are systemically compromised,
Patients who are smokers,
Pregnant and lactating women,
Subjects who had undergone periodontal therapy in the past 3 months,
Subjects who were under antibiotic therapy in the past 3 months,
Patients with metabolic diseases related to bone,
Subjects on drugs that might alter bone metabolism.
|
|
|
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 |
Mean clinical attachment level
Mean probing pocket depth
Mean gingival index
Mean plaque index
Mean bone fill
Mean alkaline phosphatase level in gingival crevicular fluid
|
Baseline, 15th day, 60th day, 3rd month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2026 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 a randomized, single blind, parallel group, single center trial comparing the efficacy of two different adjuncts with non-surgical periodontal therapy in 45 patients with periodontitis that will be conducted for one and a half yeas in a single center in India. The outcome measures are improved clinical (probing pocket depth, clinical attachment loss, plaque index, gingival index) , biochemical (Human Gingival crevicular Fluid (GCF) Alkaline Phosphatse levels) and radiologic parameters (bone fill)
|