| CTRI Number |
CTRI/2026/02/104062 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation and Comparasion of pinhole surgical technique with using and without using A PRF with polynucleotide hyaluronic acid gel in the treatment of multiple adjacent gingival recession defects: A randomised controlled trial. |
|
Scientific Title of Study
|
Comparative evaluation of pinhole surgical technique with and without A PRF immersed with polynucleotide hyaluronic acid gel in the treatment of multiple adjacent gingival recession defects: A randomised controlled 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 Harsh Kulkarni |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College And Research Centre |
| Address |
104 Department of Periodontics And Implantology Ranjeet Deshmukh Dental College And Research Centre Digdoh Hills Hingna Road Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9096290294 |
| Fax |
|
| Email |
Harshkul2019@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College And Research Centre |
| Address |
104 Department Of Periodontics And Implantology Ranjeet Deshmukh Dental College And Research Centre Digdoh Hills Hingna Road Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College And Research Centre |
| Address |
104 Department Of Periodontics And Implantology Ranjeet Deshmukh Dental College And Research Centre Digdoh Hills Hingna Road Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071468 |
| Fax |
|
| Email |
drrajashrikolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Road Nagpur State Maharashtra Country India 440019 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College And Research Centre |
| Address |
Digdoh Hills Hingna Road Nagpur 440019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 RAJASHRI KOLTE |
Ranjeet Deshmukh Dental College And Research Centre |
104 DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY NAGPUR 440019
Nagpur
MAHARASHTRA |
9011071468
drrajashrikolte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pinhole Surgical Technique |
Patients with Class one or two Multiple Adjacent Gingival Recession Defects treated using Pinhole Surgical Technique |
| Intervention |
Pinhole Surgical Technique using A PRF immersed with polynucleotide hyaluronic acid gel |
Patients with Class one or two Multiple Adjacent Gingival Recession Defects to be treated using Pinhole Surgical Technique with A PRF immersed with polynucleotide hyaluronic acid gel |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients
Patient with healthy and stable soft tissue architecture
Co-operative motivated and hygiene conscious patients
Patients exhibiting bilateral Millers Class one or two MAGRD
Patients with more than one mm of attached gingiva at gingival recession sites
Patients who gave written consent for the procedure |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating females
Tobacco smokers
Uncontrolled medical conditions precluding elective surgery
Untreated periodontal conditions
Patients treated with any medication known to cause gingival hyperplasia
Drug and alcohol abuse
In addition teeth with furcation defects non vital teeth carious teeth warranting restorations and mobility more than grade two will also be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare Pinhole surgical technique (PST) with and without A PRF immersed with polynucleotide hyaluronic acid gel in the treatment of Multiple adjacent gingival recession defects (MAGRD) clinically and radiographically by CBCT |
Baseline 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate Probing depth (PD) Clinical attachment level (CAL) Width of keratinized gingiva (WKG) Recession depth (RD) and Mean root coverage (MRC)in MAGRD when treated with PST alone at baseline 3 and 6 months postoperatively
To evaluate PD CAL WKG RD and MRC in MAGRD when treated using PST with A PRF immersed with polynucleotide hyaluronic acid gel at baseline 3 and 6 months postoperatively
To compare PD CAL WKG RD and MRC in MAGRD when treated using PST with and without A PRF immersed with polynucleotide hyaluronic acid gel at baseline 3 and 6 months postoperatively
To evaluate and compare Gingival thickness (GT) in MAGRD when treated using PST with and without A PRF immersed with polynucleotide hyaluronic acid gel at baseline and 6 months postoperatively by CBCT |
Baseline 3 and 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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="1"
Months="6"
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
|
This study will be conducted to evaluate and compare Pinhole Surgical technique with and without A PRF immersed with polynucleotide hyaluronic acid gel in the treatment of Multiple adjacent gingival recession defects clinically and radiographically. Total of 30 subjects exhibiting bilateral Miller’s class I or II maxillary anterior gingival recession defect visiting the Department of Periodontics at Ranjeet Deshmukh Dental College and Research Centre Nagpur will be recruited as per the inclusion criteria will participate in the study The participants will be divided as Group I Class I or II MAGRD to be treated using PST alone. Group II Class I or II MAGRD treated using PST with A PRF immersed with polynucleotide hyaluronic acid gel Written informed consent will be taken from the patients who wish to enrol in the study Pinhole Surgical technique with and without A PRF immersed with polynucleotide hyaluronic acid gel in the treatment of maxillary anterior recession defects is evaluated clinically and radiographically using Cone Beam Computed Tomography. Probing depth (PD) Clinical attachment level (CAL) Width of keratinized gingiva (WKG) Recession depth (RD) Gingival Thickness (GT) Mean root coverage (MRC) in Multiple Adjacent Gingival Recession Defects when treated with PST alone and when treated using PST with A PRF immersed with polynucleotide hyaluronic acid gel will be evaluated and compared at baseline 3 and 6 months postoperatively
|