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CTRI Number  CTRI/2024/03/063609 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   osseodensification drilling technique comparing over tradiotional implant drilling technique in thin jaw bone- A prospective randamised control study 
Scientific Title of Study   Osseodensification: A definite edge in the narrow alveolar ridge over the conventional drilling technique protocol. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohanasatheesh 
Designation  post graduate 
Affiliation  Sree Balaji Dental College and Hospital 
Address  Department of Periodontics velechery main road pallikaranai chennai
pallikaranai chennai
Chennai
TAMIL NADU
600100
India 
Phone  9841779846  
Fax    
Email  satheeshdent@sbdch.bharathuniv.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Mohanvaliathan 
Designation  Professor 
Affiliation  Sree Balaji Dental College and Hospital 
Address  Department of Periodontics velechery main road pallikaranai chennai
pallikaranai chennai
Chennai
TAMIL NADU
600100
India 
Phone  9841779846  
Fax    
Email  mohan211@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Mohanasatheesh 
Designation  post graduate 
Affiliation  Sree Balaji Dental College and Hospital 
Address  Department of Periodontics velechery main road pallikaranai chennai
pallikaranai chennai

TAMIL NADU
600100
India 
Phone  9841779846  
Fax    
Email  satheeshdent@sbdch.bharathuniv.ac.in  
 
Source of Monetary or Material Support  
sree Balaji dental college Velachery Rd, VGP Rajesh Nagar, Pallikaranai, Chennai, Tamil Nadu 600100  
 
Primary Sponsor  
Name  sree Balaji Dental College 
Address  velechery main road pallikaranai chennai 600100 
Type of Sponsor  Research institution and hospital 
 
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 
Mohanasatheesh  sree Balaji Dental College & hospital  sree Balaji Dental college, velechery main road, pallikarani chennai
Chennai
TAMIL NADU 		 9841779846

satheeshdent@sbdch.bharathuniv.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institute Ethics Committee(clinical trial)  Approved 
Institutional Review board Sree Balaji Denatl College and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  with missing teeth 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Placement of dental implant in narrow ridge using Densah osseodensifgication bur  Placement of dental implant in narrow ridge using Osseodensification technique 
Comparator Agent  Placement of implant using conventional drilling using convenntional drills dentium drills  Placement of implant in narrow dental ridges using conventional drilling technique with non densiffication mode using Dentium drills 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  adequate oral hygiene
patient willing to participate
minimum one missing teeth
 
 
ExclusionCriteria 
Details  Heavy smokers
pregnant and lactating women
medically compromised patients
chemotherapy and radiation undergoing patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Measuring bone width using CBCT.  0, 3 and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Insertion torque value
Isq value 		 3 months 6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 3 
Date of First Enrollment (India)   26/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [satheeshdent@sbdch.bharathuniv.ac.in].

  6. For how long will this data be available start date provided 30-12-2022 and end date provided 30-12-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   To Compare the effectiveness of the newly developed Osseodensification burs to the conventional drilling burs in narrow alveolar ridge  during implant placement .
10 patient control and !0 patient comparing , Totally twenty patients are included with minimum 30 implant placmenent
 
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