| CTRI Number |
CTRI/2025/05/087626 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Covering Of Exposed Root Surface Using Two Different Root Coverage Procedures. |
|
Scientific Title of Study
|
Comparative evaluation of Clinical & aesthetic parameters Using dermal matrix graft v/s
Advanced platelet rich fibrin (a-prf) in coronally advanced Flap (caf) in treatment of class II
Gingival recessions-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 |
Swati Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
ITS Dental College, Hospital and Research Centre, Greater Noida |
| Address |
Department of Periodontology and Oral Implantology, Room No 8, 4th Floor, ITS Dental College Hospital and Research Centre, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar
Department of Periodontology and Oral Implantology, Room No 8, 4th Floor, ITS Dental College Hospital and Research Centre, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9871289480 |
| Fax |
|
| Email |
swati2022@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivesh Kumar Mishra |
| Designation |
Reader |
| Affiliation |
ITS Dental College, Hospital and Research Centre, Greater Noida |
| Address |
Department of Periodontology, Room No 8, 4th Floor, ITS Dental College Hospital And Research Centre, Knowledge Park 3, Greater Noida,Gautam Buddha Nagar
Department of Periodontology, Room No 8, 4th Floor, ITS Dental College Hospital And Research Centre, Knowledge Park 3, Greater Noida,Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9953579219 |
| Fax |
|
| Email |
dr.shiveshmishra@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Swati Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
ITS Dental College, Hospital and Research Centre, Greater Noida |
| Address |
Department of Periodontology, Room no. 8 , 4th floor, ITS DentalL College Hospital And Research Centre, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar
Department of Periodontology, Room no. 8 , 4th floor, ITS DentalL College Hospital And Research Centre, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9871289480 |
| Fax |
|
| Email |
swati2022@its.edu.in |
|
|
Source of Monetary or Material Support
|
| ITS Dental College, Hospital And Research Centre, Knowledge Park 3, Greater Noida - 201310,India |
|
|
Primary Sponsor
|
| Name |
Swati Singh |
| Address |
Room no. 8 , 4th floor, ITS DentalL College Hospital And Research Centre, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar, 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 |
| Swati Singh |
ITS Dental College, Hospital And Research Centre, Greater Noida |
Room no. 8 , 4th floor, ITS DentalL College Hospital And Research Centre, Knowledge Park 3, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9871289480
swati2022@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS DENTAL COLLEGE, HOSPITAL AND RESERACH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Advance Platelet rich fibrin (A-prf) in coronally advanced flap in treatment of class II gingival recession |
Autologous Material used for treating class II gingival recession
Follow up duration: 6 months |
| Intervention |
Dermal matrix graft in Coronally advance flap in treatment in class II gingival recession |
Graft Material for treatment of class II gingival recessions
Follow up duration: 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Class II recession as per PD Miller (1985)
Maxillary and Mandibular Anterior Teeth
Both Males and female
Age between 18 to 50 years |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females
Patient undergoing Periodontal Therapy
Patients receiving antibiotic therapy
Teeth with aberrant frenal attachment
Patients with Thin gingival biotype
Patients with TFO |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare clinical and aesthetic parameters by the use of Dermal Matrix Graft in Coronally Advanced Flap and Advanced Platelet Rich Fibrin in Coronally Advance Flap for the treatment of Class II Gingival Recession |
At Baseline, 3 Months, 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of dermal matrix graft in coronally advance flap and advance platelet rich fibrin in coronally advance flap in treating class II gingival recession
To evaluate clinical and aesthetic parameters using dermal matrix graft in coronally advance flap in class II gingival recession
To evaluate clinical and aesthetic parameters using advance platelet rich fibrin in coronally advance flap in treating class II gingival recession |
Baseline, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
02/06/2025 |
| 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="2"
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
|
Twenty-four patients with Class II gingival recession were enrolled and randomly assigned to two groups: Group 1 received CAF with DMG, while Group 2 received CAF with A-PRF. Clinical parameters, including probing depth, clinical attachment level, gingival index, plaque index, recession depth, and recession width, were recorded at baseline, 3 months, and 6 months. Both groups underwent non-surgical periodontal therapy before surgical intervention. |