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CTRI Number  CTRI/2020/01/022787 [Registered on: 15/01/2020] Trial Registered Prospectively
Last Modified On: 03/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare The Clinical And Radiographic Outcome Of Immediate And Delayed Loaded Implant Prosthesis For Missing Mandibular First Molar. 
Scientific Title of Study   A Randomized Single Blind Clinical And Radiographic Study To Compare Immediate Versus Delayed Loading Of Implants For Replacement Of Missing Mandibular First Molar. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita Singh 
Designation  Post Graduate  
Affiliation  Shree Bankey Bihari Dental College and Research Centre 
Address  Department of Periodontics Shree Bankey Bihari Dental College and Research Centre 0.5 Km Ahead Masuri Canal NH-24 Masuri Ghaziabad-201302 UP INDIA

Ghaziabad
UTTAR PRADESH
201302
India 
Phone  7838482477  
Fax    
Email  drankitasingh91@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Gupta  
Designation  Professor & Head of Depatement  
Affiliation  Shree Bankey Bihari Dental College and Research Centre 
Address  Department of Periodontics Shree Bankey Bihari Dental College and Research Centre 0.5 Km Ahead Masuri Canal NH-24 Masuri Ghaziabad-201302 UP INDIA

Ghaziabad
UTTAR PRADESH
201302
India 
Phone  9971581158  
Fax    
Email  neha.jalaj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankita Singh 
Designation  Post Graduate 
Affiliation  Shree Bankey Bihari Dental College and Research Centre 
Address  Department of Periodontics Shree Bankey Bihari Dental College and Research Centre 0.5 Km Ahead Masuri Canal NH-24 Masuri Ghaziabad-201302 UP INDIA

Ghaziabad
UTTAR PRADESH
201302
India 
Phone  7838482477  
Fax    
Email  drankitasingh91@gmail.com  
 
Source of Monetary or Material Support  
Shree Bankey Bihari Dental college Research Institute 0.5 Km Ahead Masuri Canal,NH-24 Masuri Ghaziabad-201302 UP India 
 
Primary Sponsor  
Name  Department of Periodontics 
Address  Shree Bankey Bihari Dental college Research Institute 0.5 Km Ahead Masuri Canal,NH-24 Masuri Ghaziabad-201302 UP India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ankita Singh  Department of Periodontics Shree Bankey Bihari Dental college Research Institute 0.5 Km Ahead Masuri Canal,NH-24 Masuri Ghaziabad-201302 UP India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ankita Singh  Shree Bankey Bihari Dental College & Research Centre,Department of Periodontics ,Room number- 402  Department of Periodontics Room no- 402
Ghaziabad
UTTAR PRADESH 		 7838482477

drankitasingh91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shree Bankey Bihari Dental College & Research Centre Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy individuals with edentulous site in the region of mandibular first molar.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Delayed loading of implants supported prosthesis in relation to mandibular first molar.  Delayed prosthetic loading will be done After three months of implant placement in relation to the edentulous mandibular first molar. 
Intervention  Immediate loading of implants supported prosthesis in relation to mandibular first molar.   Immediate prosthetic loading will be done within two weeks of implant placement in relation to the edentulous mandibular first molar. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  The patients having edentulous space in the region of the mandibular first molar with sufficient bone quantity and quality.
History of extraction not less than three months before planning for the implant.
Co-operative, motivated and hygiene conscious patients. 
 
ExclusionCriteria 
Details 
History of bruxism
Immunocompromised patient
Smokers 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To achieve Stability of implants  At Baseline,3,6,9 Months. 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Modified Gingival index
Probing Depth
Implant Mobility
Marginal Bone levels
Peri- implant Radiolucency. 		 At Baseline,3,6,9 Months. 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="14" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/01/2020 
Date of Study Completion (India) 15/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 Ths Study is a Randomized Single Blind Study which aims to compare the clinical and radiographic outcome between Immediate versus Delayed loaded implant supported prosthesis for a study period of nine months includind fourteen patients with missing mandibbular first molar that will be conducted in a single centrein Ghaziabad,Uttar Pradesh,India. 
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