| CTRI Number |
CTRI/2021/06/034454 [Registered on: 29/06/2021] Trial Registered Prospectively |
| Last Modified On: |
11/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Stability of Dental Implants Placed by Osseodensification Technique and Conventional Technique in upper jaw – A Randomized Controlled Trial. |
|
Scientific Title of Study
|
Comparative Evaluation of Stability of Threaded Conical Dental Implants Placed by Osseodensification Technique and Conventional Drilling Technique in Maxilla – 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 Apurva Dashputra |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
202 Department of
Periodontology
Government Dental
College and Hospital
Nagpur GMC Campus
Medical Square Nagpur
440003
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9665807740 |
| Fax |
|
| Email |
apurvadashputra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Karemore |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
202 Department of
Periodontology
Government Dental
College and Hospital
Nagpur GMC Campus
Medical Square Nagpur
440003
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9011098882 |
| Fax |
|
| Email |
drperiodon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apurva Dashputra |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
202 Department of
Periodontology
Government Dental
College and Hospital
Nagpur GMC Campus
Medical Square Nagpur
440003
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9665807740 |
| Fax |
|
| Email |
apurvadashputra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Nagpur |
|
|
Primary Sponsor
|
| Name |
Government Dental College and Hospital Nagpur |
| Address |
Government Dental College and Hospital Nagpur GMC Campus Medical Square Nagpur 440003 |
| Type of Sponsor |
Government 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 Apurva Dashputra |
Government Dental College and Hospital Nagpur |
202 Department of Periodontology Government Dental College and Hospital Nagpur GMC Campus Medical Square Nagpur 440003
Nagpur
MAHARASHTRA |
9665807740
apurvadashputra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Dental College and Hospital Nagpur |
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 |
Conventional Implant Osteotomy |
Dental Implant Placement using Conventional Implant Osteotomy Technique |
| Intervention |
Osseodensification |
Dental Implant Placement using Osseodensification Technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically healthy patients requiring and opting Dental Implants for replacement of missing teeth in maxilla.
2)Patients Having D3 or D4 bone density.
3)Patients having ability to maintain optimum oral hygiene.
|
|
| ExclusionCriteria |
| Details |
1)Patients with systemic diseases that contraindicates the surgery, immune compromised patients.
2)Past or present treatment with intravenous amino-bisphosphonates.
3)Pregnant or lactating females.
4)Patients not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary stability as implant stability quotient (ISQ) with the resonance frequency analysis device |
At the time of Implant Placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary stability as implant stability quotient (ISQ) with the resonance frequency analysis device |
At Second Stage Impalnt Surgery |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
Difference in the Primary and Secondary Stability of Implants
Placed by two techniques (Osseodensification technique and Conventional
Drilling) used for Implant Bed Preparation.
|
|