| CTRI Number |
CTRI/2026/03/105467 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study comparing gum healing around dental implants with and without Titanium-prepared Platelet Rich Fibrin (T-PRF) |
|
Scientific Title of Study
|
Comparative evaluation of peri-implant mucosa by using Titanium-prepared platelet rich fibrin (T-PRF) under Sohn’s Poncho technique: A clinico-radiographic 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 Shaikh Arshiya Anjum Shaikh Yousuf |
| Designation |
PG Student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE & HOSPITAL,HYDERABAD |
| Address |
Department of Periodontics Room no.317, 2nd floor Government Dental College and Hospital, Afzal Gunj, Osmania General Hospital Campus, Hyderabad, Telangana, 500012
Hyderabad
TELANGANA
500012
India |
| Phone |
8669783178 |
| Fax |
|
| Email |
arshiya08anjum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Santhi Priya |
| Designation |
Professor and HOD Dept of Periodontics |
| Affiliation |
GOVERNMENT DENTAL COLLEGE & HOSPITAL,HYDERABAD |
| Address |
Department of Periodontics Room no.317, 2nd floor , Osmania General Hospital Campus, Afzal Gunj, Hyderabad, Telangana, 500012
Hyderabad
TELANGANA
500012
India |
| Phone |
|
| Fax |
|
| Email |
drpriyatweety@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaikh Arshiya Anjum Shaikh Yousuf |
| Designation |
PG student |
| Affiliation |
GOVERNMENT DENTAL COLLEGE & HOSPITAL,HYDERABAD |
| Address |
Department of Periodontics Room no.317, 2nd floor Government Dental College and Hospital, Afzal Gunj, Osmania General Hospital Campus, Hyderabad, Telangana, 500012
Hyderabad
TELANGANA
500012
India |
| Phone |
8669783178 |
| Fax |
|
| Email |
arshiya08anjum@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self sponsorShaikh Arshiya Anjum Shaikh Yousuf |
| Address |
H.No.16-11-16/1/1/1/A,Flat No.302,3rd Floor,Zain Tower,Saleem Nagar Colony, Malakpet, Hyderabad -500036 Telangana |
| Type of Sponsor |
Other [Self sponsor(Shaikh Arshiya Anjum Shaikh Yousuf)] |
|
|
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 Shaikh Arshiya Anjum |
Government Dental College and Hospital Hyderabad |
Department of Periodontics Room no.317, 2nd floor , Osmania General Hospital Campus, Afzal Gunj, Hyderabad, Telangana, 500012
Hyderabad
TELANGANA |
8669783178
arshiya08anjum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(Affiliated to Ethic committee Usmania Medical College Koti Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
healing abutment with T-PRF |
T-PRF placement along with healing abutment under Sohn poncho technique 3 month after implant surgery |
| Comparator Agent |
Healing abutment without T-PRF |
Healing abutment placement without using T-PRF 3 month after implant surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with no systemic disease
Periodontally healthy patients
Patients with good oral hygiene
Patients having missing maxillary or mandibular posterior teeth
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Patients with poor compliance
Edentulous site with infections
Patients with smoking habit
Pregnancy and Lactation
Patients with any malocclusion or parafunctional habits
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of width and thickness of Peri-implant mucosa |
At baseline(at the time of healing abutment placement),and at 3 months after healing abutment placement. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
16/03/2026 |
| 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="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Only few clinical studies have assessed the efficacy of T PRF membrane in improving the peri implant mucosal thickness and width of keratinized mucosa And also minimal or no literature is available for advocation of Sohns poncho technique during second stage of healing abutment placement Hence the goal of study is to evaluate soft tissue changes around implant while placing T PRF along with healing abutment during second stage surgery
|