| CTRI Number |
CTRI/2025/03/082071 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation and Comparasion of pinhole surgical technique with and without T-PRF 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 T-PRF 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 Ritika Gattani |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre Nagpur |
| Address |
Department of Periodontics and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7038002941 |
| Fax |
|
| Email |
ritikarg2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashri Kolte |
| Designation |
Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre Nagpur |
| Address |
Department of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre 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 Nagpur |
| Address |
Department of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre 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 Nagpur |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| 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 Rajashri Kolte |
Ranjeet Deshmukh Dental College and Research Centre Nagpur 440019 |
104 Department of Periodontics and Implant Dentistry
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: Y999||Unspecified external cause status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pinhole Surgical Technique |
Patients with Class one or two Multiple Adjacent Gingival Recession Defects to be treated using Pinhole Surgical Technique |
| Comparator Agent |
Pinhole Surgical Technique using T-PRF |
Patients with Class one or two Multiple Adjacent Gingival Recession Defects treated using Pinhole Surgical Technique with T-PRF |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 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
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare Pinhole surgical technique (PST) with and without T-PRF 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 T-PRF at baseline, 3 and 6 months postoperatively.
To compare PD, CAL, WKG, RD and MRC in MAGRD when treated using PST with and without T-PRF at baseline, 3 and 6 months postoperatively.
To evaluate and compare Gingival thickness (GT) in MAGRD when treated using PST with and without T-PRF at baseline and 6 months postoperatively by CBCT.
|
Baseline, 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
12/03/2025 |
| 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="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 T-PRF in the treatment of Multiple adjacent gingival recession defects clinically and radiographically. Total of 25 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/ II MAGRD to be treated using PST alone. Group II: Class I/ II MAGRD treated using PST with T-PRF. Written informed consent will be taken from the patients who wish to enroll in the study. Pinhole Surgical technique with and without T-PRF 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 T-PRF will be evaluated and compared at baseline, 3 and 6 months postoperatively.
|