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CTRI Number  CTRI/2021/09/036513 [Registered on: 15/09/2021] Trial Registered Prospectively
Last Modified On: 23/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study to Evaluate the Success of Dental Implants Using Three Different Implant Site Preparation Techniques 
Scientific Title of Study   Comparative Evaluation of Implant Stability with Three Osteotomy Techniques  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nandita Venkatesh 
Designation  Post Graduate Student  
Affiliation  A B Shetty Memorial Institute of Dental Sciences Deralakatte 
Address  Department of Prosthodontics and Crown & Bridge A B Shetty Memorial Institute of Dental Sciences Deralakatte Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7560810602  
Fax    
Email  nandita.19dpro05@student.nitte.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj Shetty 
Designation  HOD 
Affiliation  A B Shetty Memorial Institute of Dental Sciences Deralakatte Mangaluru 
Address  Department of Oral Implantology A B Shetty Memorial Institute of Dental Sciences Deralakatte Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845267087  
Fax    
Email  drmanojshetty@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Nandita Venkatesh 
Designation  Post Graduate Student  
Affiliation  A B Shetty Memorial Institute of Dental Sciences Deralakatte Mangaluru 
Address  Department of Prosthodontics and Crown & Bridge A B Shetty Memorial Institute of Dental Sciences Deralakatte Mangaluru

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7560810602  
Fax    
Email  nandita.19dpro05@student.nitte.edu.in  
 
Source of Monetary or Material Support  
Department of Oral Implantology A B Shetty Memorial Institute of Dental Sciences Deralakatte Mangaluru 575018  
 
Primary Sponsor  
Name  Department of Oral Implantology 
Address  A B Shetty Memorial Institute of Dental Sciences Deralakatte Mangaluru - 575018  
Type of Sponsor  Other [Private Dental College ] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Manoj Shetty  Head of Department Department of Oral Implantology A B Shetty Memorial Institute of Dental Sciences Deralakatte Mangaluru  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nandita Venkatesh  A B Shetty Memorial Institute of Dental Sciences  Department of Oral Implantology, ABSMIDS, Mangaluru - 575018
Dakshina Kannada
KARNATAKA 		 7560810602

nandita.19dpro05@student.nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee A B Shetty Memorial Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Persons missing maxillary posterior teeth and wanting replacement with implant supported prostheses 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Square threaded endosseous implants, standard drilling placement   Implant stability to be assessed using resonance frequency analysis immediately post placement and 3 and 6 months post placement 
Intervention  Square threaded endosseous implants, Summer’s osteotomy technique, osseodensification burs   implant stability to be assessed using resonance frequency analysis immediately post placement and 3 and 6 months post placement 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult males or females with
1.Adequate bone length and bone width for implant placement.
2.Completely healed edentulous sites
 
 
ExclusionCriteria 
Details  1.Presence of systemic diseases such as diabetes mellitus, hypertension, oral pathology in their soft or hard tissues
2.Harmful oral habits such as bruxism and smoking.
3.Active infection in the area or an apical cyst.
4.Limited mouth opening
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Implant stability with ISQ values   Immediately after implant placement, 3 and 6 months post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of the implant stability using the three different osteotomy techniques   Immediately after implant placement, 3 and 6 months post operatively 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2021 
Date of Study Completion (India) 20/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is a randomized, parallel group, active controlled study, evaluating and comparing the implant stability of dental implants using three different osteotomy techniques; standard drilling placement, Summer’s osteotomy technique and using osseodensification burs. The primary outcome measure is the implant stability measured in ISQ values using resonance frequency analysis immediately after placement, 3 months and 6 months post operatively.   
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