| CTRI Number |
CTRI/2023/07/055771 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
16/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparitive study of dynamic navigated Dental implant surgery with that of fully guided surgery. |
|
Scientific Title of Study
|
"COMPARATIVE EVALUATION OF PROSTHETICALLY DRIVEN IMPLANT PLACEMENT USING DYNAMIC NAVIGATION SYSTEM WITH THAT OF FULLY GUIDED PROCEDURE" - A RANDOMIZED CLINICAL PROSPECTIVE STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrHaripriyanka K Raj |
| Designation |
Senior lecturer, Department of Prosthodontics, Room no :3 |
| Affiliation |
K.L.E.S Institute of Dental Sciences |
| Address |
20,tumkur road, yeshwanthpur suburb II stage, Raja Industrial estate, Bangalore 560022
20,tumkur road, yeshwanthpur suburb II stage, Raja Industrial estate, Bangalore 560022
Bangalore
KARNATAKA
560022
India |
| Phone |
9945500372 |
| Fax |
|
| Email |
drpriya.kuchipudi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrHaripriyanka K Raj |
| Designation |
Senior lecturer, Department of Prosthodontics, Room no 3 |
| Affiliation |
K.L.E.S Institute of Dental Sciences |
| Address |
20,tumkur road, yeshwanthpur suburb II stage, Raja Industrial estate, Bangalore 560022
20,tumkur road, yeshwanthpur suburb II stage, Raja Industrial estate, Bangalore 560022
Bangalore
KARNATAKA
560086
India |
| Phone |
9945500372 |
| Fax |
|
| Email |
drpriya.kuchipudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrHaripriyanka K Raj |
| Designation |
Senior lecturer |
| Affiliation |
K.L.E.S Institute of Dental Sciences |
| Address |
222, 1st Main, 2nd Stage, West of chord road, Bangalore
20,tumkur road, yeshwanthpur suburb II stage, Raja Industrial estate, Bangalore 560022
Bangalore
KARNATAKA
560086
India |
| Phone |
9945500372 |
| Fax |
|
| Email |
drpriya.kuchipudi@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.L.E.Ss Institute of Dental Sciences, Bangalore-560022 |
|
|
Primary Sponsor
|
| Name |
Dr. Haripriyanka K Raj |
| Address |
222, 1st Main, 2nd Stage, West of chord road, Bangalore 560086 |
| 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 Haripriyanka K Raj |
K.L.E.S Institute of dental sciences |
Room no:3, Department of Prosthodontics,
20, yeshwanthpur suburb,2nd stage,Raja industrial estate,Bangalore
Bangalore
KARNATAKA |
9945500372
drpriya.kuchipudi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partially edentulous or Complete edentulous |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Accuracy of Dental Implant Surgery |
Comparision of Dynamic Navigation surgery with that of
Fully Guided Dental Implant Surgery |
| Intervention |
Surgical Intervention |
Dynamic navigated Surgery and fully guided dental implant surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• All Patients aged above 18-65 years with partially or fully edentulism requiring Implant supported restorations.
• Subjects with sufficient bone for support and stabilization of the dynamic navigation devices and thermoplastic stent.
• patients agreed for the procedure and provided their informed consent to be part of the study.
|
|
| ExclusionCriteria |
| Details |
• Any local and/or systemic condition hindering dental implant surgery.
• Patients smoking > 5 cigarettes per day.
• Patient requiring grafting procedures
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prosthetically 3D positioning of dental implant |
Prosthetically 3D positioning of dental implant |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hard tissue changes
Temperature rise in Osteotomy site
Reduced surgical time |
4 years |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
16/08/2023 |
| 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="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A systematic review is formulated with regards to the topic. Systematic review was formulated with the title of 3D positioning of Dental Implants using Dynamic navigation- A systematic Review Proceedings of Systematic Review Data collection of review done with PubMed search engine with following PICO criteria Population- Partially and complete edentulous ridges Intervention- Dynamic Navigated Surgery Comparison – Fully Guided surgery Outcome – Accurate planned 3D positioning Total Number of study identified – 234 |