| CTRI Number |
CTRI/2024/08/072547 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of Dentinal Graft versus Platelet Rich Fibrin in Immediate Implant Placement: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Clinico- Radiological Evaluation of Dentinal Graft against Platelet Rich Fibrin in Extraction Sockets with Immediate Implant Placement- A Randomized Control 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 |
Krishna Pampatwar |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department of oral and maxillofacial surgery, Ground Floor 004 SPDC Building, Sawangi
Wardha MAHARASHTRA 442001 India |
| Phone |
9225560368 |
| Fax |
|
| Email |
krishnapampatwar308@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhushan Mundada |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department of oral and maxillofacial surgery, Ground Floor 004 SPDC Building, Sawangi
Wardha MAHARASHTRA 442001 India |
| Phone |
9975629137 |
| Fax |
|
| Email |
pbmundada18@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhushan Mundada |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education & Research |
| Address |
Department of oral and maxillofacial surgery, Ground Floor 004 SPDC Building, Sawangi
Wardha MAHARASHTRA 442001 India |
| Phone |
9975629137 |
| Fax |
|
| Email |
pbmundada18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha India 442107 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Wardha India 442107 |
| Type of Sponsor |
Private medical college |
|
|
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 Krishna Pampatwar |
Sharad Pawar Dental College |
Department of oral and Maxillofacial surgery (004)SPDC Building Sawangi Meghe 442001 Wardha MAHARASHTRA |
9225560368
krishnapampatwar308@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research |
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 |
| Intervention |
Dentinal graft |
Dentinal graft will be placed before implant placed in freshly prepared socket after extraction |
| Comparator Agent |
PRFM graft |
PRFM graft will be placed before implant placed in freshly prepared socket after extraction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.All patient undergoing mandibular posterior teeth extraction with immediate implant placement.
2.All patients with radiographic and clinical evidence suggestive of intact alveolar osseous architecture
3.Presence of at least 2 mm of bone beyond the root apex (Above canal).
4.Patients with type I extraction sites (four-wall socket) as per Salama and Salama (1993) classification.
|
|
| ExclusionCriteria |
| Details |
1 All patients with underlying systemic health conditions that may impede the osseous healing cascade, such as diabetes, osteoporosis, hematologic disorders, and titanium allergies.
2.All patients with D-4 bone quality.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The success of the implant will be determined by the crestal bone changes and stability after 6 months following the use of DENTINAL GRAFT and PRFM |
Assessment will be done at 3rd and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
27/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Dental
implant therapy has advanced significantly, providing consistent outcomes for
patients. While reduced residual ridge height is common with delayed loading
implants, various procedures prevent post-extraction alveolar ridge resorption.
These include socket grafting materials, for bone regeneration, and
instantaneous implant placement. Flapless surgery preserves bone
vascularization, reducing the need for multiple surgeries and enhancing.
Atraumatic extraction minimizes tissue stress, protecting remaining bone.
Peri-implant voids often occur due to the horizontal gap distance between the
implant and alveolar socket This study aims to evaluate the efficacy of Dentinal graft (DG) against Platelet
rich fibrin matrix (PRFM) in immediate implant procedures utilizing a two-stage protocol. This will be a prospective randomized controlled trial will be
conducted, wherein patients fulfilling the inclusion criteria will be equally
divided into two groups. Group A will comprise of patients in which DENTINAL
graft will be placed before implant placed in freshly prepared socket after
extraction‘, whereas in Group B patients will receive PRFM. After extraction
socket Functional Outcomes will be measured using parameters like Clinical and
Radiographic measurement The success of
the implant will be determined by the crestal bone changes and stability after
6 months following the use of PRFM and DENTINAL GRAFT. |