Clinical trial NCT06268639: Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique
Official title: Evaluation of Bone Density Before and After Placement of Implant Using Osseodensification Technique
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: King Khalid University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Increase in Bone Density at Implant Sites Using Osseodensification Technique
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
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