- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06148012
Investigation of Marginal Bone Loss in Implants with Different Surface Properties and Geometric Designs: a Retrospective Clinical Study
Purpose: The aim of this study was to investigate the influence of surface characteristics and geometric design on marginal bone loss and bone quality in dental implants.
Materials and Methods: A total of 378 implants from 114 patients were evaluated in this study using panoramic and periapical radiographs. Implants were categorized into 19 subgroups according to the jaw where they were placed, length, diameter, surface preparation, type of prosthetic superstructure, and neck design. Radiological evaluations were conducted based on radiographs obtained at the time of implant placement and 3 months after prosthetic loading. After obtaining measurements of marginal bone loss and fractal analysis data, the significance of differences between groups was statistically evaluated.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Rize, Merkez, Turkey, 53000
- Recep Tayyip Erdogan University Oral an Mazillofacial Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Implants with a minimum length of 8 mm
- Implants with a minimum diameter of 3.5 mm
- Availability of panoramic and periapical radiographs at T0 (immediately after surgery) and T1 (3 months after prosthetic loading).
Exclusion Criteria:
- Presence of a systemic condition hindering dental implant treatment and routine check-ups
- History of regular alcohol/tobacco use
- Presence of severe parafunctional habits (bruxism, etc.)
- Prior grafting procedures before dental implant placement
- Implant failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RTEU Oral and Maxillofacial Surgery
|
Digital panoramic radiographs taken during the patients' treatment periods (T0, T1) were used in the study. Measurements of marginal bone levels on radiographs were performed using the "Image J" software. The distance between the most coronal part of the implant neck and the most apical part of the defect caused by marginal bone loss was measured. Fractal analysis (FA) was conducted on panoramic radiographs (OPG) with a size of 2952x1435 pixels and a depth of 32 bits. FA on these radiographs at T0 and T1 times was performed using the box counting method determined by White and Rudolp with the ImageJ program(23). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal Bone Loss around different dental implants
Time Frame: 180 days
|
Number of Participants: 114 Number of Dental Implants: 378 Implants will be categorized into 19 subgroups according to the jaw where they were placed, length, diameter, surface preparation, type of prosthetic superstructure, and neck design. Radiological evaluations will be conducted based on radiographs obtained at the time of implant placement and 3 months after prosthetic loading. The distance between the most coronal part of the implant neck and the most apical part of the defect caused by marginal bone loss(millimeters) will be measured. The magnification ratio will be calculated by comparing the previously recorded implant length with the length measured on the software, allowing the determination of the actual value of MBL. |
180 days
|
|
Fractal values around dental implant radiographs
Time Frame: 180 days
|
A total of 378 implants from 114 patients will be evaluated in this study using panoramic and periapical radiographs.
Implants will be categorized into 19 subgroups according to the jaw where they were placed, length, diameter, surface preparation, type of prosthetic superstructure, and neck design.
Radiological evaluations will be conducted based on radiographs obtained at the time of implant placement and 3 months after prosthetic loading.
And measurement pre op post op fractal values
|
180 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTEUOralandMaxilloFacialSurg
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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