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

NCT06268639 | Not Yet Recruiting

• 2 other identifiers: ECM#2024-216RGP1/347/44
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Osseodensification; Dental implants; Bone density; Primary stability; Osteotomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Osseodensification in Dental Implant Surgery

EXPERIMENTAL

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

Interventions

Osseodensification 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.

Osseodensification in Dental Implant Surgery

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Khalid University: lead

Related Publications (1)

• 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.

  PMID: 39560860 DERIVED

Central Study Contacts

Sunil Kumar, MDS

CONTACT

+966595220377; snu@kku.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study employs an open-label design, where no masking is applied. This means that the participants, care providers, investigators, and outcomes assessors are all aware of the intervention being administered. Given the nature of the intervention-osseodensification technique used in dental implant surgery-it is not feasible to blind the study participants or the clinical staff involved in the procedure and assessment to the intervention being studied. The open-label approach allows for direct observation of the intervention's effects on bone density without the complexity of blinding, which is often the case in surgical and procedural interventions where the treatment administered is evident.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study employs a single-group, interventional model to examine the impact of osseodensification on bone density at dental implant sites. It involves a sequential process starting from pre-operative bone density assessment using DentaScan CT, followed by surgical intervention using osseodensification drills, and concluding with a post-operative bone density evaluation to compare changes. This approach aims to determine if osseodensification can significantly enhance bone density and stability around implant sites, thereby potentially improving the success rates of dental implants. The methodology includes detailed pre-operative and post-operative assessments, with statistical analysis conducted to evaluate the effectiveness of the intervention.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: March 20, 2024
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share