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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06148012
Other study ID # RTEUOralandMaxilloFacialSurg
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date November 25, 2023

Study information

Verified date November 2023
Source Recep Tayyip Erdogan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3
Est. completion date November 25, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
dental implant
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).

Locations

Country Name City State
Turkey Recep Tayyip Erdogan University Oral an Mazillofacial Surgery Rize Merkez

Sponsors (1)

Lead Sponsor Collaborator
Recep Tayyip Erdogan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Marginal Bone Loss around different dental implants 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
Primary Fractal values around dental implant radiographs 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
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