| CTRI Number |
CTRI/2025/07/091645 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate gum and bone changesin immediate implant placement with Titanium Prepared Platelet Rich Fibrin TPRF membrane and customized abutment placement |
|
Scientific Title of Study
|
Volumetric Analysis of Periimplant Hard and Soft Tissue Changes in Immediate Implant Placement incorporating Titanium Prepared Platelet Rich Fibrin TPRF Membrane and Customized Provisionalization A prospective 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 |
Korrai Pavani |
| Designation |
Post graduate student |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Department of periodontics room no 6
GITAM Dental college and hospital
Gandhinagar campus
Rushikonda
Visakhapatnam
Visakhapatnam 4
Department of periodontics room no 6
GITAM Dental college and hospital
Gandhinagar campus
Rushikonda
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
8639774618 |
| Fax |
|
| Email |
pavaninandan13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Naveen Vital kumar |
| Designation |
Professor |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
Department of perioodntics
room no 6
GITAM Dental College and Hospital
Gandhi Nagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
530045
Department of perioodntics
room no 6
Gandhi Nagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
530045
ANDHRA PRADESH
530045
India |
| Phone |
8985886906 |
| Fax |
|
| Email |
ngidijal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Korrai Pavani |
| Designation |
Post graduate student |
| Affiliation |
GITAM Dental College and Hospital |
| Address |
GITAM Dental College and Hospital
Gandhi Nagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
530045
Gandhi Nagar Campus
Rushikonda
Visakhapatnam
Andhra Pradesh
530045
ANDHRA PRADESH
530045
India |
| Phone |
8639774618 |
| Fax |
|
| Email |
pavaninandan13@gmail.com |
|
|
Source of Monetary or Material Support
|
| GITAM Dental College and Hospital
Department of Periodontics
Gandhi Nagar campus
Rushikonda
Visakhapatnam
Andhra Pradesh
530045 |
|
|
Primary Sponsor
|
| Name |
Korrai Pavani |
| Address |
Door no 13 1114 1 Beside Sri Anjana School
Old Arilova
Visakhapatnam
Andhra Pradesh
530045 |
| 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 |
| Korrai Pavani |
GITAM Dental college and hospital |
Department of periodontics
Room no 6
GITAM dental college
Gandhi Nagar Campus
Rushikonda
Visakhapatnam
530045
Visakhapatnam
ANDHRA PRADESH |
8639774618
pavaninandan13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GITAM Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Placement of tprf
and customized abutment |
Placement of implant followed by tprf placement and customized abutment in immediate extraction socket |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with good systemic health
Patients with decayed Fractured
endodontically failed single rooted
teeth advised for extraction
Healthy soft tissue and adequate
keratinized tissue at the implant site
Patients willing to comply with the
study follow up schedule
|
|
| ExclusionCriteria |
| Details |
Current Smokers
Patients with para-functional habits bruxism that could compromise implant success
Previous surgical periodontal therapy
at the implant site
Patients with uncontrolled systemic
diseases and conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To clinically and radiographically evaluate the
volumetric changes in peri-implant crestal bone
levels and gingival thickness and keratinized
mucosa width Pink Esthetic Score |
At baseline 3 6 and 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate Pink Esthetic Score
|
To evaluate Pink Esthetic Score at baseline 3 6 and 9 months |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
14/08/2025 |
| 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
|
12 patients will be selected following atraumatic extraction of tooth the implant is placed within the extraction socket A temporary implant cylinder or sandblasted abutment is then positioned followed by the fabrication of a customized composite provisional restoration titanium-Prepared Platelet Rich Fibrin (TPRF) is then sandwiched between the customized provisional restoration and the socket to enhance healing and soft tissue stability The implant will be functionally loaded with a permanent crown after a healing period of four months crestal bone levels keratinized mucosa width gingival thickness pink esthetic scores will be evaluated at baseline 3 6 and 9 months |