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CTRI Number  CTRI/2021/07/034554 [Registered on: 02/07/2021] Trial Registered Prospectively
Last Modified On: 25/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Increasing implant stability using bonedensification technique. 
Scientific Title of Study   Comparative Evaluation of Implant Stability Using Osseodensification Technique Versus Conventional Technique 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  CHITITHOTI RISHITHA 
Designation  Post graduate 
Affiliation  ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES 
Address  Depratment of periodontics room number 6 Anil Neerukonda Institute of Dental Sciences Sangivalasa Visakhapatnam - 531162
Depratment of periodontics room number 6 Anil Neerukonda Institute of Dental Sciences Sangivalasa Visakhapatnam - 531162
Visakhapatnam
ANDHRA PRADESH
531162
India 
Phone  8897134572  
Fax    
Email  chrishitha1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Y V Sashi kanth 
Designation  MDS 
Affiliation  ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES 
Address  Depratment of periodontics room number 6 Anil Neerukonda Institute of Dental Sciences Sangivalasa Visakhapatnam - 531162
Depratment of periodontics room number 6 Anil Neerukonda Institute of Dental Sciences Sangivalasa Visakhapatnam - 531162
Visakhapatnam
ANDHRA PRADESH
531162
India 
Phone  9246675440  
Fax    
Email  yvsashikanth@gmail.com  
 
Details of Contact Person
Public Query
 
Name  CHITITHOTI RISHITHA 
Designation  Post graduate 
Affiliation  ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES 
Address  Depratment of periodontics room number 6 Anil Neerukonda Institute of Dental Sciences Sangivalasa
Depratment of periodontics room number 6 Anil Neerukonda Institute of Dental Sciences Sangivalasa Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
523001
India 
Phone  8897134572  
Fax    
Email  chrishitha1@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Anil Neerukonda Institute of Dental Sciences 
Address  Depratment of periodontics room number 6 Anil Neerukonda Institute of Dental Sciences Sangivalasa Visakhapatnam 
Type of Sponsor  Other [Private Dental college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
CHITITHOTI RISHITHA  ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES  Depratment of periodontics room number 6 Anil Neerukonda Institute of Dental Sciences Sangivalasa VISAKAPATNAM - 531162
Visakhapatnam
ANDHRA PRADESH 
8897134572

chrishitha1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ANIDS institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z463||Encounter for fitting and adjustment of dental prosthetic device,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional technique  to evaluate primary and secondary implant stability using conventional drills. 
Intervention  Osseodensification  to evaluate the primary and secondary implant stability using osseodensification drills 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Adequate oral hygiene
2)Patients between 20 to 65 years
3)Patients with missing teeth in the posterior region 
 
ExclusionCriteria 
Details  1)Medically compromised subjects. (uncontrolled diabetics)
2)General contraindications against implant treatment (radiotherapy, immunodeficiency, etc.).
3)Untreated, periodontal disease, or caries.
4)Pregnancy.
5)Heavy smoker (>10 cigarettes per day).
6)Poor oral hygiene.
7)Parafunctional habits.
8)Alcohol or drug abuse. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary stability is measured immediately after implant placement.

 
Day 1
 
 
Secondary Outcome  
Outcome  TimePoints 
2. Primary and early secondary stability are measured at 6 weeks interval (healing abutment will be placed to avoid injury at the implant site).
3. Secondary implant stability is measured at the 12th week (before the abutment placement)
 
6th week, 12th week 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   02/08/2021 
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   Main Dissertation 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The key vital role for the long term success of implant mainly depends on osseointegration. Osseointegrated implants have better bone quality and stability. The concept of osseointegration was introduced by BRANEMARK & Colleagues in the year 1969. This osseointegration was based on the primary stability, which was achieved immediately after the implant placement. To obtain biomechanically stable implants, high bone density and bone quality are the ideal requisites, indirectly resulting in better secondary stability. SALAH HUWAIS, in the year 2013, introduced a novel technique that helps in the densification of bone by autografting the individual’s bone within the osteotomy site wall. This in due results in creating a suitable environment for osteoblast nucleation on the autografted bone, which is close to the integrated implant body. Thus, new bone growth formation enhances within the osteotomy site. This physical and biomechanical interlocking results in higher primary stability values, which is mainly attributed to condensation and preservation of the bone by lateral compaction. This OSSEODENSIFICATION procedure has come under the limelight in recent times as it increases both the implants’ mechanical stability and peri-implant bone density.

 
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