Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique (BIDOS)

The study investigates the impact of osseodensification drills on bone density changes surrounding dental implants. Osseodensification, a novel technique, is hypothesized to enhance primary stability of implants by densifying bone rather than removing it during osteotomy. Participants undergo pre-operative and post-operative DentaScan CT analyses to measure bone density in Hounsfield units at apical, mesial, and distal positions around the implant sites. This intervention-based research aims to quantify the benefits of osseodensification in improving bone quality and implant success. Data from 32 sites, analyzed via the Radiant DICOM software, undergo statistical examination using SPSS to ascertain significant differences in bone density pre- and post-surgery. The outcome could redefine surgical approaches in implantology, emphasizing osseodensification's role in achieving superior bone-implant integration.

Study Overview

• Status: Not yet recruiting
• Conditions: Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique
• Intervention / Treatment: Procedure: Osseodensification

Detailed Description

Study Design The research is an interventional study targeting a single group of patients slated for dental implant placement, incorporating a total of 32 implant sites for detailed analysis. The study is meticulously designed to track each participant through sequential phases, including pre-operative evaluation, the surgical intervention employing osseodensification drills, and a thorough post-operative assessment to gauge the technique's impact on bone density and implant stability.

Pre-operative Evaluation Participants undergo a comprehensive dental examination before the surgical procedure, which includes DentaScan CT imaging conducted at Rohilkhand Medical College and Hospital's Department of Radiology. The imaging, analyzed using Radiant DICOM software, facilitates precise measurement of bone density at strategic locations around the planned implant sites, specifically at apical, mesial, and distal positions. These measurements, recorded in Hounsfield units, establish baseline bone density values for each site, grouped as Group 1 for analysis.

Surgical Procedure Implant placement surgeries are carried out under local anesthesia in the Department of Prosthodontics. Initial osteotomy sites are prepared using a pilot drill, followed by the application of osseodensification drills (VT1525 and VT2535) in a non-cutting, counterclockwise direction to expand and densify the bone at the osteotomy sites. This technique is theorized to enhance primary stability of the implants by improving bone density.

Post-operative Evaluation Post-surgery, patients receive instructions and medications for post-operative care. A follow-up DentaScan CT is performed to assess changes in bone density at the implant sites, comparing these post-operative measurements to the pre-operative baselines to evaluate the effectiveness of the osseodensification technique.

Data Analysis Data from pre-operative and post-operative evaluations are systematically recorded and analyzed using SPSS software. A student paired t-test is utilized to ascertain the significance of changes in bone density, with a p-value of less than 0.05 deemed statistically significant.

Objective The primary aim is to ascertain whether the use of osseodensification drilling techniques yields a measurable improvement in bone density around implant sites, potentially enhancing dental implant success rates by fostering better primary stability and facilitating osseointegration.

Significance The study seeks to offer empirical evidence supporting the application of osseodensification in dental implantology. By rigorously assessing the technique's impact on bone density and implant stability, the research endeavors to make a meaningful contribution to surgical practices in dental implant placement, aiming to ultimately enhance patient outcomes by leveraging this innovative technique.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sunil Kumar, MDS; Phone Number: +966595220377; Email: snu@kku.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with partial or complete edentulous ridge in the maxilla or mandible.

Exclusion Criteria:

• Presence of a fractured jaw.
• General bone or blood disorders that may affect osseointegration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Osseodensification in Dental Implant Surgery; The arm involves participants undergoing dental implant surgery with the use of osseodensification drills. This technique is intended to enhance bone density and improve the primary stability of the implants by compacting bone rather than removing it during the osteotomy process. The study aims to assess the impact of osseodensification on bone density at the implant sites, comparing pre-operative and post-operative bone density measurements to evaluate the effectiveness of this intervention.

Procedure: Osseodensification; The intervention, osseodensification, involves a surgical technique using specific drills (e.g., Densah burs) rotated in a counterclockwise direction to compact bone rather than remove it, thereby increasing bone density around the implant site. This method is aimed at improving the primary stability of dental implants by creating a denser bone environment, which theoretically should lead to better osseointegration and long-term success of the implant. The technique distinguishes itself from traditional drilling by preserving and enhancing bone structure, which is crucial for the success of dental implants in patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in Bone Density at Implant Sites Using Osseodensification Technique	The primary outcome measure is the change in bone density at the dental implant sites, measured in Hounsfield units (HU), from pre-operative to post-operative stages. The study aims to quantify the effectiveness of the osseodensification technique in enhancing bone density around the implant sites, thereby potentially improving the primary stability of dental implants. The outcome will be assessed using DentaScan CT imaging analyzed with Radiant DICOM software to compare bone density values at apical, mesial, and distal positions relative to each implant site before and after the surgical intervention.	3-6 months

Collaborators and Investigators

• Sponsor: King Khalid University

Study record dates

Study Major Dates

• Study Start (Estimated): March 20, 2024
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dental implants; Bone density; Osseodensification; Osteotomy; Primary stability
• Other Study ID Numbers: ECM#2024-216; RGP1/347/44 (Other Grant/Funding Number: King Khalid University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study aims to share specific individual participant data related to the osseodensification technique's effect on bone density around dental implant sites. Data to be shared includes pre-operative and post-operative bone density measurements at specified implant sites, measured in Hounsfield units, and statistical analyses comparing these measurements. The data will be anonymized to protect participant confidentiality and shared with researchers who provide a methodologically sound proposal for purposes of advancing knowledge in dental implant stability and bone density impacts. Data will be available upon request following publication of the study results, subject to approval by the study's ethical review board and under a data-sharing agreement that specifies data use, security requirements, and data destruction upon project completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No