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CTRI Number  CTRI/2019/03/017904 [Registered on: 01/03/2019] Trial Registered Prospectively
Last Modified On: 29/03/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The success of Dental implant treatment in dentistry is dependent on mainly two factors that is, firmness of dental implant with jaw bone and bone loss around dental implant.In this study evaluation is done for above factors. 
Scientific Title of Study   “Clinical evaluation of effect of placement of abutment–implant complex/microgap,machined collar on implant stability and marginal bone level changes of unloaded 2-piece implants”- Clinical study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Macchindra Vikhe 
Designation  Associate Professor 
Affiliation  Rural Dental College. 
Address  Department of Prosthodontics,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  919822811117  
Fax  912422273413  
Email  drdeepak_mvikhe@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seemit Shah 
Designation  HOD and Professor 
Affiliation  Pravara institute of medical sciences. 
Address  Department of Oral Surgery,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9823129828  
Fax  912422273413  
Email  nirav_seemit@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Macchindra Vikhe 
Designation  Associate Professor 
Affiliation  Pravara institute of medical sciences. 
Address  Department of Prosthodontics,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  919822811117  
Fax  912422273413  
Email  drdeepak_mvikhe@yahoo.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Pravara Institute of Medical Sciences 
Address  Department of Prosthodontics,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736  
Type of Sponsor  Private medical 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 
Deepak Vikhe  Rural Dental College.  Department of Prosthodontics,Rural Dental College,Loni-BK,Rahata,Ahmednagar,Pravara Institute Of Medical Sciences(Deemed University),Loni BK,Tal:Rahata,Dist:Ahmednagar,Maharashtra,413736
Ahmadnagar
MAHARASHTRA 
919822811117
912422273413
drdeepak_mvikhe@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee,Pravara Institute of Medical Sciences(Deemed University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adults with adequate bone support for implant placement with few teeth missing.  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Subjects with adequate bone support for implant placement.

2. Implants placed in mandibular posterior region  
 
ExclusionCriteria 
Details  1. Subjects with no systemic diseases. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
There will be less bone loss around Dental Implant with better treatment.
 
3,6 Months
 
 
Secondary Outcome  
Outcome  TimePoints 
Healing around dental implant will be better.Less complications and less failure of dental implant after Laoading.  6 Months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   07/03/2019 
Date of Study Completion (India) 26/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="11"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

20  dentate subjects with one or two missing teeth will be selected. The study procedure will be explained to the subjects and with prior consent of the subjects the study will be further conducted.All necessary investigations before implant placement will be carried out. 7 implants will be placed with abutment implant complex/microgap,machined collar supracrestally and other 7 implants will be placed with abutment implant complex/microgap,machined collar subracrestally by following proper manufacturer’s instructions.

Implant stability will be measured by periotest instrument immediately after implant placement and 6  months after implant placement with implant mount in place in  both technniqe. The readings will be correlated with a grading scale provided by manufactures of periotest instrument. This study was also undertaken to evaluate marginal bone loss on the mesial and distal side of the implant, by  Digital opg  in both technique at the end of six months after placing the implants, but before prosthetically loading it. A  Digital opg and an IOPA  X-ray was taken on the day of implant placement, one hour after  the surgery. Crestal bone loss was measured on opg taken on the same machine, which was used for opg at the time of implant placement. The distance between the top of the implant and the level of crestal bone (first bone to implant contact) along the implant surface on mesial and distal side was measured on the opg  machine monitor, using its software. The measured value was auto-corrected by the in-built software for radiographic magnification factor.

All readings will be filled in the proforma for the study as given below and results will be analyzed.

Keeping this in mind, a study will be  undertaken to evaluation of  effect of placement of abutment–implant complex/microgap,machined collar on implant stability and marginal bone level changes of  unloaded  2-piece implants six months after the implant placement. The site was  kept common in  lower posterior region .

 
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