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CTRI Number  CTRI/2025/04/084691 [Registered on: 13/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of osseodensification with iPRF on implant stability quotient and crestal bone level: A randomized controlled clinical trial. 
Scientific Title of Study   Effect of Osseodensification with and without iPRF on implant stability quotient and crestal bone level: A randomized controlled clinical 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  Gitanjali P 
Designation  postgraduate student 
Affiliation  Manipal College of Dental College 
Address  DEPARTMENT OF PERIODONTOLOGY, Room no 7 , 4th floor, Manipal College of Dental Sciences, Kasturba Medical College , Lighthouse hill road, Hampankatta,Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  7353196259  
Fax    
Email  gpoddar1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neetha J Shetty 
Designation  Professor, Manipal College of Dental Sciences, Mangalore-575001  
Affiliation  Manipal College of Dental College 
Address  DEPARTMENT OF PERIODONTOLOGY, Room no 7 4th floor Manipal College of Dental Sciences Kasturba Medical College Lighthouse hill road Hampankatta Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880858025  
Fax    
Email  neetha.rajesh@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Neetha J Shetty 
Designation  Professor, Manipal College of Dental Sciences, Mangalore-575001  
Affiliation  Manipal College of Dental College 
Address  DEPARTMENT OF PERIODONTOLOGY, Room no 7 4th floor Manipal College of Dental Sciences Kasturba Medical College Lighthouse hill road Hampankatta Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9880858025  
Fax    
Email  neetha.rajesh@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of dental Sciences, Affiliate of manipal academy of higher education, lighthouse hill road , hampankatta mangalore Karnataka. 575001 
 
Primary Sponsor  
Name  Gitanjali P 
Address  Department of Periodontology, Room no. 7, 4th floor, Manipal college of dental sciences, Kasturba Medical College, lighthouse hill road, Hampankatta, Mangalore. Karnataka 575001 
Type of Sponsor  Private medical college 
 
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 GITANJALI P  Manipal College of Dental Sciences Mangalore  Dept. Of Periodontology, room no. 7, 4th floor, Manipal College of Dental Sciences, light house hill road, hampankatta, Mangalore, Karnataka, 575001
Dakshina Kannada
KARNATAKA 
7353196259

gpoddar1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Implant placement using osseodensification drills with iPRF.  Implant placement in systemically healthy patient using osseodensification drills along with iprf in the period of 6 months. 
Intervention  Implant placement using osseodensification drills.  Implant is placed in systemically healthy patient using osseodensification drills duration of 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients included in the study should be at least 18 years of age.
2. Adequate interocclusal space in maxillary or mandibular region.
3. Minimum ridge height and Width should be ≥10mm and ≥3mm, respectively.
4. Patients who will be agreeing to participate in the study by signing the informed consent. 
 
ExclusionCriteria 
Details  1. Patients with known systemic diseases which can affect normal bone healing.
2. Patients with parafunctional habits.
3. Patients who are chronic smokers.
4. Patients who present with signs of active infection.
5. Immunocompromised individuals.
6. Patient with previous or active treatment with steroids or bisphosphonates. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment    
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Implant stability quotient (ISQ)
Crestal bone level 
Implant stability quotient (ISQ) : at base line, 4th week, at the time of supra-structure placement.
Crestal bone level : at base line, 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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   N/A 
Date of First Enrollment (India)   04/06/2025 
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 Applicable 
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  

Dental implants have become a cornerstone in modern restorative dentistry, offering reliable solutions for replacing missing teeth. Achieving optimal implant stability and successful osseointegration are critical for the long-term success of implant therapy. Conventionally, implant placement involves subtractive drilling techniques to create osteotomies, which may compromise bone density and volume, particularly in areas with low-quality or thin cortical bone. While this approach is widely accepted, the challenges associated with bone remodeling and the time required for osseointegration remain areas of ongoing research and innovation.

In 2013, Huwais and Meyer presented an innovative approach for preparing implant sites that addresses bone defects by forming a densified osteotomy with reduced heat generation and a technique that does not cut bone, which is known as the osseodensification technique utilizing Densahâ„¢ Burs that promote bone densification throughout the osteotomy process.

Unlike conventional drilling, this new technique proposes the method of bone compaction through the application of controlled deformation due to rolling and sliding contact along the inner surface of the osteotomy with the rotating lands of the densifying bur. Growth factors, such as bone morphogenic proteins and platelet-derived growth factor (PRF), have been used in numerous trials to promote bone development in the affected areas. In the treatment of the perimplant bony defect, PRF has shown osteoinductive qualities and speeds up bone recovery.

A biomaterial made from human blood called platelet rich fibrin (PRF) is a part of a platelet concentrate that is produced by centrifugation. It is frequently used in dentistry and medicine for tissue regeneration, post-operative recuperation, and rehabilitation. The hemostatic, adhesion, and healing qualities of fibrin plasma have benefited neurological, ophthalmic, reconstructive, dental, cardiovascular, and thoracic procedures.

Platelet-rich fibrin (PRF), which was originally developed by Choukroun et al in 2001, is a 2nd-generation platelet concentrate that represents the development of the therapeutic use of a platelet gel that aims to collect platelets, leukocytes, and related cytokines in a fibrin clot. Whitman et al concluded that wound healing is improved by using platelet concentrates instead of fibrin glue. A specific quantity of progenitor cells is drawn from the bloodstream via injectable PRF, which offers the advantages of advanced PRF in the form of a liquid. It has demonstrated exceptional efficacy in regenerative medicine and oral surgery.

The PRF application likely increases implant stability as proved by a higher implant stability quotient (ISQ). Thus, the application of PRF favors rapid osseointegration.Therefore, this randomized control clinical trial study the effect of Osseodensification with iPRF on implant stability quotient and crestal bone level.

 
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