| CTRI Number |
CTRI/2026/03/107151 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of lowering of gums in adults using gum surgery with healing proteins and Tooth Derived Gel |
|
Scientific Title of Study
|
Clinical evaluation of coronally advanced flap with concentrated growth factor and emdogain in the management of Miller's Class I and II localized gingival recession - 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 Nilanjana Majumdar |
| Designation |
PG Student |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Campus 15 Rd, Chandaka Industrial Estate, K I I T University, Patia, Bhubaneswar, Odisha. Kalinga Institute of Dental Sciences. Department of Periodontology, 1st Floor, Room No - 04
Khordha
ORISSA
751024
India |
| Phone |
9330505812 |
| Fax |
|
| Email |
2489028@kids.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Jalaluddin |
| Designation |
Professor |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Campus 15 Rd, Chandaka Industrial Estate, K I I T University, Patia, Bhubaneswar, Odisha. Kalinga Institute of Dental Sciences. Department of Periodontology. 1st Floor, Room No -04
Khordha
ORISSA
751024
India |
| Phone |
9338131843 |
| Fax |
|
| Email |
drjalal1979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilanjana Majumdar |
| Designation |
PG Student |
| Affiliation |
Kalinga Institute of Dental Sciences |
| Address |
Campus 15 Rd, Chandaka Industrial Estate, K I I T University, Patia, Bhubaneswar, Odisha. Kalinga Institute of Dental Sciences. Department of Periodontology, 1st Floor, Room No-04
Khordha
ORISSA
751024
India |
| Phone |
9338131843 |
| Fax |
|
| Email |
drjalal1979@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nilanjana Majumdar |
| Address |
Campus 15 Rd, Chandaka Industrial Estate, K I I T University, Patia,Bhubaneswar, Odisha 751024. Kalinga Institute of Dental Sciences. Department of Periodontology 1st Floor Room No- 04 |
| 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 Nilanjana Majumdar |
Kalinga Institute of Dental Sciences |
Department of Periodontology. 1st Floor, Room No- 04
Khordha
ORISSA |
9330505812
2489028@kids.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES(KIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coronally Advanced Flap in treatment of Millers Class I and II localized gingival recession |
Patients diagnosed with localized gingival recession will undergo root coverage surgery using the coronally advanced flap technique under local anesthesia. Following flap reflection and root surface preparation,the flap will be coronally advanced to completely cover the recession defect and stabilized using appropriate suturing technique. |
| Intervention |
Coronally Advanced Flap with Concentrated Growth Factor and Emdogain in treatment of Millers Class I and II localized gingival recession |
Patients diagnosed with localized gingival recession will undergo root coverage surgery using the coronally advanced flap technique under local anesthesia. Following flap reflection and root surface preparation,Enamel matrix derivative (Emdogain) will then be applied to the conditioned root surface. The flap will be coronally advanced to completely cover the recession defect and stabilized using appropriate suturing techniques.In another group,CGF membrane will be placed over the prepared root surface and recession defect,The flap will be coronally advanced to completely cover the recession defect and stabilized using appropriate suturing techniques |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Millers Class I and Class II gingival recession
2.Patient consent for the procedure
3.Patients with good oral hygiene
|
|
| ExclusionCriteria |
| Details |
1.Patients with systemic disease
2.Patients with oral habits
3.Patients on antibiotics more than 6 months
4.Patients with thin biotype
5.Patients with malocclusion
6.Patients with cervical abrasion
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Width of keratinized gingiva,
Recession depth, Mean percentage of root coverage |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Gingival Index
Plaque Index |
Baseline, 3 months, 6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2026 |
| 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="3"
Months="0"
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
|
Gingival recession leads to root exposure and aesthetic concerns. The coronally advanced flap (CAF) is a commonly used technique for treating Miller’s Class I and II recession defects. Adjuncts like concentrated growth factor (CGF) and Emdogain may enhance healing and clinical outcomes.
This clinical study aims to evaluate and compare the effectiveness of CAF with CGF and CAF with Emdogain in the management of localized gingival recession by assessing clinical parameters such as recession depth, and percentage of root coverage. |