| 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
|
|
|
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
|
|
|
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. |