| CTRI Number |
CTRI/2024/07/070164 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Check the effects of Tissue Changes in around the implant Immediate Implant with Socket Shield Technique |
|
Scientific Title of Study
|
Comparative Evaluation of Periimplant Tissue Changes in Immediate Implant with Socket Shield Technique and Delayed Implant with Socket Shield Preservation Technique: Randomized 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 |
Hari Lal Kumawat |
| Designation |
Post-Graduate Student |
| Affiliation |
Government Dental College And Hospital Nagpur |
| Address |
Department of Periodontology Government Dental College And Hospital Nagpur GMC Campus Medical Sqaure 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
7028522913 |
| Fax |
|
| Email |
harryqazx@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College And Hospital Nagpur |
| Address |
Department of Periodontology Government Dental College And Hospital Nagpur GMC Campus Medical Sqaure 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422203650 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Phadnaik |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College And Hospital Nagpur |
| Address |
Department of Periodontology Government Dental College And Hospital Nagpur GMC Campus Medical Sqaure 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9422203650 |
| Fax |
|
| Email |
drmbphadnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Society of Periodontology India Nagpur, 440003 |
|
|
Primary Sponsor
|
| Name |
Indian Society of Periodontology |
| Address |
Dr Ashish Jain Secretary ISP 721 Phase 3B-1 Mohali SAS Nagar 160061 |
| Type of Sponsor |
Other [] |
|
|
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 Hari Lal Kumawat |
Government Dental College and Hospital Nagpur |
Department of Periodontology Government Dental College and Hospital Nagpur GMC Campus Medical Square Nagpur 440003
Nagpur
MAHARASHTRA |
7028522913
harryqazx@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental Collgege and Hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sites Receiving Implants by Delayed Implant with Socket Shield Preservation Technique |
After completion of facial shield preparation and ensuring its stability, the socket will be loosely packed with allograft particles and it is sealed with either a membrane or platelet rich fibrin membrane (PRF) and sutured. After 3 months later, similar to group 1 surgery is proceeded.
T0-at baseline , T1-at 3 months , T2- at 6 months |
| Comparator Agent |
Sites Receiving Implants by Immediate Implant with Socket Shield Technique |
First decoronation of tooth will be done using a bur and high speed handpiece under copious irrigation. The root will be sectioned mesiodistally using a surgical bur that will inserted to the apex and the palatal root portion will be removed. Further, socket curettage will be performed to eliminate any remaining tissue debris, followed by gentle probing to rule out shield mobility. Implant will be placed following osteotomy and flap will be reapproximated with sutures.
T0-at baseline,T1- at 3 months, T2- 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Systemically healthy patients requiring and opting Dental Implants for replacement of missing teeth in maxilla and mandible.
2) Age range: 20-65 years
3) Good oral hygiene and periodontal status
4) Adequate amount of bone volume at implant site allowing to perform the surgery.
|
|
| ExclusionCriteria |
| Details |
1) Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
2) Pregnant or lactating females.
3) H/o radiotherapy, smokers, parafunctional habits, acute and chronic infection.
4) Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) To evaluate Implant stability, Pink esthetic score, Crestal bone loss, bone thickness, Bone height, Patient satisfaction index in immediate implant with socket shield technique
b) To evaluate Implant stability, Pink esthetic score, Crestal bone loss, bone thickness, Bone height, Patient satisfaction index in delayed implant with socket shield preservation technique
|
T0- At Baseline Implant Placement
T1- After 3 Months of Implant Placement
T2- After 6 Months of Implant Placement
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Implant stability, Pink esthetic score, Crestal bone loss, Bone thickness, Bone height, Patient satisfaction index in immediate implant with socket shield technique and delayed implant with socket shield preservation technique |
T0- At Baseline Implant Placement
T1- After 3 Months of Implant Placement
T2- After 6 Months of Implant Placement |
|
|
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 3 |
|
Date of First Enrollment (India)
|
26/07/2024 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| Immediate Implant :- The placement of a dental implant in an extraction socket at the time of extraction or explantation is known as immediate implant placement Delayed Implant:- Delayed placement of implant signifies the implant placement in edentulous areas where healing has completed with new bone formation after the loss of tooth/teeth. Socket shield technique : In this technique, during the time of extraction, some portion of the buccal root is preserved and an immediate implant is placed. The root fragments function like a shield and preserve the resorption of the buccal bone and thus enhance the contour of the tissues and increase the esthetic outcomes | After extensive search of literature no study was found comparing periimplant tissue changes in immediate implant with socket shield technique and delayed implant with socket shield preservation technique. To evaluate and compare Periimplant tissue changes in immediate implant with socket shield technique and delayed implant with socket shield preservation technique | |