Retrospective Evaluation of Prosthetic Complications and Peri-implant Bone Resorption in Implant-supported Single Unit Fixed Restorations

November 25, 2024 updated by: Özer İşisağ
This study evaluated the one-year outcomes of implant-supported single-tooth fixed restorations used to replace missing teeth. The aim was to assess the success rates of dental implants and identify potential complications during treatment. A total of 100 individuals aged between 20 and 64 participated in the study. Patients were evaluated one year after their implant treatments through clinical examinations and radiographic imaging.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim: The aim of this study was to retrospectively investigate the prosthetic complications and peri-implant bone loss by clinical and radiological examination at the 12th month of implantsupported single-unit fixed restorations.

Materials and Methods: In this retrospective study, 100 volunteer patients, aged between 20 and 64, who received implant-supported single-member fixed restoration treatment, were scanned from the archives and included. The patients were scanned from the archives, called for 12-month follow-ups, and clinical and radiographic evaluations were made. G*Power (G*Power Ver. 3.0.10, Franz Faul, Üniversität Kiel, Germany) package program was used to calculate the sample size. Digital radiographs (periapical-panoramic films) taken from the patients at the end of the implant treatment and at the 12th month follow-up were recorded using Planmeca Romexis® software. ImageJ, a digital image analysis program, was used to evaluate marginal bone loss on radiographs (ImageJ 1.54g- Wayne Rasband and Contributons, National institutes of Health, USA). In evaluating the success and survival of the implants, the criteria in the consensus decisions published at the International Oral Implantology Congress in 2007 were taken as basis. In addition, prosthetic complications such as chipping, screw loosening and decementation; Its relationship with anatomical localization, implant length, implant diameter, abutment type, superstructure material, occlusal table and the condition of the opposing arch was evaluated.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Afyonkarahisar, Turkey
        • Afyonkarahisar University of Health Sciences Faculty of Dentistry, Department of Prosthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients undergoing single-unit implant-supported restoration treatment at the Department of Prosthodontics, Afyonkarahisar University of Health Sciences

Description

Inclusion Criteria:

  • Participants were required to be over 18
  • Not to have any systemic disorders
  • Not to smoke
  • Have provided consent to the study.

Exclusion Criteria:

  • Individuals with any systemic or psychiatric disorders
  • Who did not have radiographic data immediately after prosthetic loading

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival rate
Time Frame: 12 months
12 months
Prosthetic complication rate
Time Frame: 12 months
This study evaluated the impact of various parameters, including abutment type, occlusal table width, and opposing arch condition, on prosthetic complications such as debonding (descementation), screw loosening, and chipping (porcelain fractures).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Özer İşisağ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2023

Primary Completion (Actual)

April 8, 2024

Study Completion (Actual)

April 8, 2024

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • number 2023/4 dated 07.04.2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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