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CTRI Number  CTRI/2025/07/091663 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effect of densa burs on low bone density patient on implant stability and bone loss with conventional burs 
Scientific Title of Study   A Comparative Evaluation of Implant Stability and Crestal Bone Levels Around Implants Placed by osseodensification drill and conventional technique in low density bone: clinicoradiographical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pawan Kumar 
Designation  Post graduate student 
Affiliation  Government Dental College and Hospital Chhatrapati Sambhajinagar 
Address  Room number 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9665555154  
Fax    
Email  Pawankumar151997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrMaya S Indurkar 
Designation  Dean, Professor and PG guide 
Affiliation  Government Dental College and Hospital Chhatrapati Sambhajinagar 
Address  Room number 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9823182694  
Fax    
Email  mayaindurkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrMaya S Indurkar 
Designation  Dean, Professor and PG guide 
Affiliation  Government Dental College and Hospital Chhatrapati Sambhajinagar 
Address  Room number 154, 1st floor, Government Dental College and Hospital, Chhatrapati Sambhajinagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9823182694  
Fax    
Email  mayaindurkar@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr.Pawan Kumar 
Address  Government Dental College and Hospital Chhatrapati Sambhajinagar 
Type of Sponsor  Other [Self] 
 
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 
DrPawan Kumar  Government Dental College and Hospital  Room no 154 1st floor Department of Periodontology Government Dental College and Hospital, Navkhanda, Chhatrapati Sambhajinagar, Maharashtra 431001
Aurangabad
MAHARASHTRA 
9665555154

Pawankumar151997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Partially edentulous jaw 
Patients  (1) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional drilling  Conventional drilling will be done using conventional drilling system.  
Intervention  osseodensification  Osseodensification will be done using densa burs drilling  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient in age range of 25 to 65 years.
2. Systemically healthy patients who are either partially edentulous with a single tooth missing were included in the study.
3. Patient who required implant supported prosthesis having good oral hygiene
4. Single tooth missing with D3 350 to 850 HU and D4 150 to 350 HU bone with adjacent and opposite tooth present.
 
 
ExclusionCriteria 
Details  1) Smoking and/or chewing tobacco.
2) Patients with psychosis or history of bruxism and other parafunctional habits.
3) Pregnant/ Lactating patients.
4) Patients with systemic diseases like uncontrolled diabetes mellitus or other disorders affecting bone metabolism.
5) Patients with bleeding disorder.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Implant stability  Baseline, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Crestal bone loss  Baseline, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   30/07/2025 
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="6"
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  

Implant therapy has been a very popular and successful treatment for both partial and total tooth loss in the last few decades. Osseointegration, which is the apparent direct attachment or connection of an osseous tissue to an inert, alloplastic material without intervening fibrous connective tissue. Achieving sufficient stability during the initial surgical placement is critical to the effectiveness of implant therapy and is impacted by a number of factors, including bone density, surgical technique, and implant design.

Low bone density might make it difficult to achieve adequate primary stability, which can cause healing to be delayed and success rates to be lower. The osseodensification technique was created as a novel way to improve bone density during the drilling process in order to address this problem. In contrast to conventional drilling techniques, osseodensification entails a non-subtractive drilling procedure that densifies the bone around the implant site.

By compacting the bone around the osteotomy site, osseodensification aims to improve the implant’s initial stability. Better physical interlocking between the implant and the bone is not the only benefit of this the presence of instrumented bone, which stimulates the production of new bone cells, also speeds up bone growth.

Essentially, by increasing primary stability and encouraging faster bone healing, osseodensification is a viable way to raise implant therapy success rate especially where bone density is a limiting factor.

A single tooth loss is thought to be a frequent source of cosmetic difficulties, since it can have psychological effects and result in non-physiologic occlusion due to neighbouring teeth tipping and opposing natural teeth supra-erupting.
One of the most popular ways to prepare an implant bed is to utilise instruments one size smaller than the implant’s diameter to prepare the location. In order to produce an insertion site for implants, this approach involves removing bone, which makes it challenging to provide the best primary stability at sites deficient in both amount and quality of bone.

Osseodensification is a recently developed biomechanical implant site preparation technique. During osteotomy preparation, the technique is characterised by low plastic deformation of bone, which is produced by rolling and sliding contact with a fluted densifying bur that densifies the bone with minimal heat elevation and allows for bone preservation and condensation through compaction autografting. This increases the density of bone in the peri-implant areas and enhances the mechanical stability of the implant.

Not many human studies have been conducted to compare conventional and osseodensification.

Hence, in this study we are evaluating stability and bone loss around implants placed using conventional and osseodensification.

 
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