| CTRI Number |
CTRI/2021/01/030848 [Registered on: 29/01/2021] Trial Registered Prospectively |
| Last Modified On: |
07/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate and compare immediate implant placement along with provisionalization with and without Concentrated Growth Factor-enriched bone graft |
|
Scientific Title of Study
|
Comparative evaluation of immediate implant placement & provisionalization with and without CGF-enriched bone graft
A Randomized Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinisha Bajaj |
| Designation |
PG Student |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
Department of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9284088553 |
| Fax |
|
| Email |
itsvinisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Professor Guide & HOD |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
Department of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay Kolte |
| Designation |
Professor Guide & HOD |
| Affiliation |
VSPM Dental College & Research Centre |
| Address |
Department of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071467 |
| Fax |
|
| Email |
drabhaypkolte@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104 Department of Periodontics and Implant Dentistry VSPM Dental College and research centre
digdoh hills hingna (Nagpur) |
|
|
Primary Sponsor
|
| Name |
Dr Vinisha Bajaj |
| Address |
Department of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
Maharashtra India
Ph No 9284088553
|
| 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 Vinisha Bajaj |
1 VSPM Dental College and Research Centre Nagpur 2 TRUESCAN Dental Diagnostics |
1 Department of Periodontics & Implant Dentistry
VSPM Dental College & Research Centre
Digdoh Hills Hingna Road
Nagpur 440019
2 106 Milestone Near Big Bazar Ramdaspeth Nagpur 440010 Maharashtra India
Nagpur
MAHARASHTRA |
9284088553
itsvinisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VSPM Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y998||Other external cause status, (2) ICD-10 Condition: Y998||Other external cause status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CGF enriched bone graft |
This is an interventional study in which the effect of immediate implant placement & provisionalization with and without CGF-enriched bone graft in which hard & soft tissue changes will be evaluated in the peri-implant area |
| Intervention |
Immediate implant placement with provisionalization |
This is an interventional study in which the effect of immediate implant placement & provisionalization with and without CGF-enriched bone graft in which hard & soft tissue changes will be evaluated in the peri-implant area |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1 Systemically healthy patients
2 Patient with healthy and stable soft tissue architecture
3 Sites at which minimum torque of 35 Ncm is obtained at the time of implant insertion
4 Co-operative motivated and hygiene conscious patients
5 Tooth/teeth with Grade I or II mobility required to be extracted
6 Root stumps
7 Tooth with endodontic failure or non-restorable caries or vertical fracture
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1 General contraindications to implant surgery
2 Patients with a history of irradiation in the head and neck area within the last 6 months
3 Treated or under treatment with intravenous amino-bisphosphonates
4 Smokers or patients with poor oral hygiene
5 Patients with para-functional habits
6 Pregnant or lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| hard and soft tissue changes clinically at baseline 3 & 6 months and radiographically using CBCT at baseline & 6 months post operatively |
baseline 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Soft tissue assessment with Testori Implant Esthetic Score
Bleeding on probing
Probing depth
Patient satisfaction using VAS scale
|
baseline 3 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2021 |
| Date of Study Completion (India) |
10/08/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized Controlled clinical and radiographic trial designed
to evaluate and compare the effect of immediate implant placement with provisionalization with and without CGF enriched
bone graft on hard and soft tissues in the peri implant area
Total 30 sites fulfilling the inclusion criteria in
maxillary anterior aesthetic area visiting the department of Periodontics and
Implant Dentistry at VSPM Dental College and Research Centre Nagpur will be
included in the study
Immediate implants with provisionalization will be
placed
The study population will be divided into 2 groups
GROUP
I Immediate implant placement with
provisionalization without CGF enriched bone graft
GROUP
II Immediate implant placement with
provisionalization with CGF enriched bone graft
The primary outcome will be assessment of hard &
soft tissue changes after immediate implant placement
clinically at baseline 3 and 6 months and radiographically using CBCT at
baseline and 6 months
The secondary outcome will be soft tissue assessment with
Testori implant esthetic score
Bleeding on probing
Probing depth
Patient
satisfaction using VAS scale
The brief
description of entire procedure will be given to every patient before starting
the procedure
Written
informed consent will be obtained from the patients
Clinical
parameters
1 Mombelli’s modified Plaque index (mPI)
2 Mombelli’s modified sulcular bleeding index (mSBI)
3 Probing pocket depth (PPD)
4 Soft Tissue Assessment
5 Ridge Width Measurement
Radiographic
Parameters
1 Crestal bone height
2 Buccal bone thickness
3 Ridge width
4 Vertical Distance
5 Jumping Gap
6 Measuring the radiolucent area between shoulder of implant and
bone crest |