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

NCT ID: NCT06268639

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2024-06-30

Brief Summary

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.

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.

Conditions

Evaluation of Osseointegration and Stability of Dental Implants in Bone Density Enhanced by Osseodensification Technique

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Osseodensification

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Khalid University

OTHER

Sponsor Role: lead

Responsible Party

Sunil Kumar Vaddamanu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sunil Kumar, MDS

Role: CONTACT

snu@kku.edu.sa

+966595220377

References

Vaddamanu SK, Saini RS, Vyas R, Kanji MA, Alshadidi AAF, Hafedh S, Cicciu M, Minervini G. A comparative study on bone density before and after implant placement using osseodensification technique: a clinical evaluation. Int J Implant Dent. 2024 Nov 19;10(1):56. doi: 10.1186/s40729-024-00565-8.

Reference Type: DERIVED

PMID: 39560860 (View on PubMed)

Other Identifiers

RGP1/347/44

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ECM#2024-216

Identifier Type: -

Identifier Source: org_study_id