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CTRI Number  CTRI/2021/02/031564 [Registered on: 25/02/2021] Trial Registered Prospectively
Last Modified On: 30/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparision of two recent methods of ridge split namely peizo and motorised device  
Scientific Title of Study   Comparatitive evaluation of alveolar ridge split and expansion using ultrasonic surgery ( peizo) device and motorized ridge expansion- a randomized control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha Sunil Manekar 
Designation  Associate Professor 
Affiliation  Govt Dental College & Hospital, Nagpur 
Address  room no 116, department of Oral & maxillofacial surgery government dental college and hospital gmc campus hanumannagar Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9823077626  
Fax    
Email  varsha_manekar@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Varsha Sunil Manekar 
Designation  Associate Professor 
Affiliation  Govt Dental College & Hospital, Nagpur 
Address  room no 116, department of oral & maxillofacial surgery government dental college and hospital gmc campus hanumannagar

Nagpur
MAHARASHTRA
440003
India 
Phone  9823077626  
Fax    
Email  varsha_manekar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Varsha Sunil Manekar 
Designation  Associate Professor 
Affiliation  Govt Dental College & Hospital, Nagpur 
Address  Room no 116, department Oral & maxillofacial surgery government dental college and hospital gmc campus hanumannagar nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9823077626  
Fax    
Email  varsha_manekar@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Dental College and Hospital, Nagpur, MS 
 
Primary Sponsor  
Name  Government Dental college and hospital 
Address  GMC campus, Hanumannagar, Nagpur,441401  
Type of Sponsor  Research institution 
 
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 
Dr Varsha Sunil Manekar  Govt Dental College & Hospital Nagpur  Room no 116 department of Oral and maxillofacial surgery government dental college and hospital GMC Campus Hanumanangar nagpur
Nagpur
MAHARASHTRA 		 9823077626

varsha_manekar@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committeeGDCHNagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K063||Horizontal alveolar bone loss. Ayurveda Condition: --,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  motorise ridge split device,  motorised ridge spliit kit is a newly available device for ridge split as an preprosthetic surgery. 
Comparator Agent  Ultra sonic ( peizo) bone cutting device   routinely used as device for alveolar ridge split  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. cases indicated for implant prosthesis with ridge width of 3-6mm, height 10mm and more
2. individual fit for minor surgery 
 
ExclusionCriteria 
Details  1. ridge width less than 3mm and more than 6mm
2. unfit for minor surgery 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ridge width gain  intra operatively (at baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
survival rate   six months after impalnt insertion 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2021 
Date of Study Completion (India) 30/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
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)?  

Response - NO
Brief Summary    the narrrow alveolar ridge width is a clinical condition in cases indicated for dental implant prosthesis. one of the pre prosthetic surgery before insertion of dental implants is ridge width. the conventional instrument used is osteotome and chisel. Recently introduction of peizo surgical cutting tools have become popular. The newly introduced is the motorised ridge split kit- ESSET kit. this interventional study aims to evaluate the effect of its use. 
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