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CTRI Number  CTRI/2025/08/093576 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical study on 24 patients to test whether a new drilling technique (osseodensification) can improve dental implant stability and reduce bone loss around implants.  
Scientific Title of Study   Clinical evaluation of implant stability and crestal bone loss using osseodensification technique - A randomised control trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nandini Metaliya 
Designation  Postgraduate student 
Affiliation  GDC&H Mumbai 
Address  215 , Department of Periodontology, Govt. Dental College and Hospital campus, Fort, Mumbai.
Mumbai
Mumbai
MAHARASHTRA
400001
India 
Phone  07350124082  
Fax    
Email  nandinimetaliya19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akshaya Banodkar 
Designation  Professor and Head 
Affiliation  GDC&H Mumbai 
Address  215 , Department of Periodontology, Govt. Dental College and Hospital campus, Fort, Mumbai.
Mumbai
Mumbai
MAHARASHTRA
400001
India 
Phone  9004782725  
Fax    
Email  akshayabanodkar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nandini Metaliya 
Designation  Post graduate student 
Affiliation  GDC&H Mumbai 
Address  215 , Department of Periodontology, Govt. Dental College and Hospital campus, Fort, Mumbai.
Mumbai
Mumbai
MAHARASHTRA
400001
India 
Phone  07350124082  
Fax    
Email  nandinimetaliya19@gmail.com  
 
Source of Monetary or Material Support  
215,Department of Periodontology Govt. dental college and hospital , Mumbai Fort, Mumbai 400001 India 
 
Primary Sponsor  
Name  Dr Nandini Metaliya 
Address  215,Department of Periodontology, Govt. Dental College and Hospital, St. Gorges Hospital campus, Fort, Mumbai. 400001 India 
Type of Sponsor  Other [self sponsered] 
 
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 
Dean Govt dental college and hospital St Gorges Hospital campus Fort Mumbai  Governtment dental college and hospital, Mumbai   215 , Department of Periodontology, Govt. Dental College and Hospital campus, Fort, Mumbai. Mumbai Maharashtra 400001 India
Mumbai
MAHARASHTRA 		 07350124082

nandinimetaliya19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Govt. Dental College and Hospital Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional osteotomy drilling technique  conventional bur design used for osteotomy site preparation involving any type of bone density Duration = 6 months 
Intervention  osseodensification burs  condensation autografting around osteotomy site used with D3, D4 type bone (according to Mish classification) Duration-6 months 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients exhibiting either partial edentulous ridges in maxilla or mandible.
2. Patients in age group of 21 - 50 years of either sex, being systemically healthy with diabetes and /or
hypertension under control opting for dental implants as a treatment option.
3. Patients with adequate ridge height.

4. Patient ready to give written informed consent.
5. Patients with D2,D3 and D4 density of maxillary and/or mandibular alveolar bone type.  
 
ExclusionCriteria 
Details  1.Medically compromised patients, which contraindicates the surgery, immune compromised patients.

2.Smokers and smokeless tobacco users.

3.Pregnant women and lactating mother.

4. Patients not willing for implant prosthesis. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary implant stability
Secondary implant stability
Crestal bone loss 		 baseline
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Insertion torque value


 		 At day 1 (of surgery) 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 2 
Date of First Enrollment (India)   05/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The comparison of implant stability outcomes between conventional and osseodensification techniques is essential to understand their respective impacts on the quality and quantity of bone followed by amount of osseointegration after implant placement. This study aims to assess whether osseodensification provides superior bone density compared to conventional techniques, potentially leading to improved clinical outcomes, such as better initial implant stability ,lesser loss of crestal bone, improved insertion torque, reduced healing times, and long-term success rates. Investigating these techniques could also help in refining implant protocols, particularly for patients with compromised bone quality, and guide clinicians in selecting most appropriate method for various clinical scenarios. 
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