FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088963 [Registered on: 17/06/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study will be conducted in patients with missing teeth Comparing Dental Implant Strength and Bone Health in Areas with Bone Grafts material (material which enhances bone growth) as against Naturally Healing Areas  
Scientific Title of Study   Comparative Evaluation of Implant Stability and Bone Quality in Patients with Implants Placed in Sockets with Bone Graft against Implants Placed in naturally healed sockets-A In Vivo 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  Rushikesh Kalpande 
Designation  Post graduate student  
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  202 Department of Prosthodontics Second Floor Sharad Pawar Dental College and Hospital Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9156737394  
Fax    
Email  rushikalpande1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anjali Borle  
Designation  Professor Sharad Pawar Dental College Sawangi Meghe Wardha 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  202 Department of Prosthodontics Second Floor Sharad Pawar Dental College and Hospital Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7879960525  
Fax    
Email  dranjaliborle@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rushikesh Kalpande 
Designation  Post graduate student  
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  202 Department of Prosthodontics Second Floor Sharad Pawar Dental College and Hospital Sawangi Meghe Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7879960525  
Fax    
Email  dranjaliborle@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research  
Address  202 Second Floor Department of Prosthodontics Sharad Pawar Dental College and Hospital Sawangi Meghe Wardha Maharashtra India 442001 
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 
DrRushikesh Kalpande   Sharad Pawar Dental College And Hospital   202 department of prosthodontics second floor sharad pawar dental college and hospital sawangi meghe waedha
Wardha
MAHARASHTRA 		 9156737394

rushikalpande1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z66||Do not resuscitate, (2) ICD-10 Condition: A491||Streptococcal infection, unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Implant placed in naturally healed socket without any bone graft placement  implants will be placed after 3 months in the bone graft placed socket and compare implants stability with the naturally healed socket  
Intervention  implants placed in a bone graft placed socket  Implants placed in a bone graft placed socket and will measure its stability 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients Requiring Single Tooth Implants and Sockets With Adequate Bone Volume for Implants and Nonsmokers Systemically Healthy Individuals 
 
ExclusionCriteria 
Details  Patients With Systemic Conditions Affecting Bone Metabolism and Sockets with Active Infection or Significant Bone Defects 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improved implant stability and enhanced bone quality are anticipated in graft (osseograft) sockets due to better preservation of bone volume and integration.
Comparative analysis will highlight the advantages or limitations of bone grafting in immediate implant placement. 		 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the bone quality at implant sites in grafted against a naturally healed socket  after 3 months of bone graft placement implant will be placed 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   15/07/2025 
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="2"
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  

INTRODUCTION
Dental implants are the preferred solution for missing teeth, with implant stability and bone quality being key factors for long-term success. Bone quality, which refers to the density and structure of the surrounding bone, is essential for osseointegration, the fusion of the implant with bone. Poor bone quality can lead to implant failure or delayed healing. When bone volume is insufficient, bone grafting is often used to enhance implant stability by increasing bone volume and quality. Common graft materials include autografts, allografts, xenografts, and synthetics, each with their pros and cons. However, the need for grafting remains debated, as some studies suggest implants can achieve adequate stability without additional grafting.

This study aims to compare implant stability and bone quality in patients receiving implants in grafted sockets versus naturally healed sockets.

AIM:
To assess the differences in implant stability and bone quality between implants placed in sockets with bone grafts and those in naturally healed sockets.

OBJECTIVES:

  1. Evaluate implant stability in grafted sockets with xenografts.

  2. Evaluate implant stability in naturally healed sockets.

  3. Compare bone quality between grafted and naturally healed sockets.

RATIONALE:

  1. Identify a more compatible and cost-effective graft material (osseograft).

  2. Assess whether implants have better stability in xenograft versus allograft.

  3. Examine bone quality changes after osseograft placement.

INCLUSION CRITERIA:

  1. Patients requiring single tooth implants.

  2. Sockets with sufficient bone volume for implant placement.

  3. Non-smokers and systemically healthy individuals.

EXCLUSION CRITERIA:

  1. Systemic conditions affecting bone metabolism.

  2. Sockets with active infection or significant defects.

MATERIAL AND METHODOLOGY:

  • Group A: 22 patients with naturally healed sockets. Implants placed, and peri-implant stability tested.

  • Group B: 22 patients with xenograft augmentation in single extraction sockets. Implants placed after 6 months of grafting, followed by peri-implant testing.

  • Perio test values will be compared between both groups.

Study Design: Randomized controlled trial
Study Period: 1 year
Sample Size: 44 patients, divided into two groups of 22 each.

EXPECTED OUTCOMES:
Better implant stability and bone quality are expected in grafted sockets due to enhanced bone volume preservation. The comparative analysis will highlight the effectiveness of grafting in immediate implant placement.

SIGNIFICANCE OF THE STUDY:
This research will provide insights into the role of bone grafting in implant success and help refine clinical guidelines for implant placement, improving patient outcomes.

CONCLUSION:
Optimizing implant protocols and understanding the influence of bone grafting (osseograft) are crucial for implant success. Socket grafting with materials like xenograft could improve bone quality and support predictable implant placement in sites with poor bone quality, possibly allowing for the modification of healed sites for better implant outcomes.

 
Close