Different Implant Positions for Implant Retained Mandibular Overdenture

March 12, 2024 updated by: Mansoura University

Retrospective Study on the Effect of Different Implant Positions for Implant Retained Mandibular Overdenture: Radiographic Evaluation of the Circumferential Bone Level and Bone Remodeling in the Anterior and Posterior Mandible

This study will aim to evaluate the effect of two different implant positions, lateral incisors, and canine areas, on anterior and posterior ridge resorption and bone remodeling after different periods of denture insertion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twelve patients will be recruited from a previous study (14), having two-implant mandibular overdentures. Patients recalled from the database set of the clinic of the Removable Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be grouped based on the position of the two implants.

All patients will be informed about all prosthetic procedures that will be done. Also, they will sign the consent form of the ethical committee of the faculty of dentistry, at Mansoura University.

All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will excluded from the study Patients will be divided into two groups Group A (6 patients): Patients having two mandibular implants in lateral incisor positions.

Group B (6 patients): Patients having two mandibular implants in canine positions.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • Egypt
      • Mansoura, Egypt, 54790
        • Khloud Ezzat

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

Description

Inclusion Criteria:

  • Patients with mandibular two implants retained overdenture opposing complete edentulous maxillary arch,
  • attended the previous follow-up recalls with previous CBCT examination.

Exclusion Criteria:

  • Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lateral incisor group
Patients having two mandibular implants in lateral incisor positions.
Other: over-denture
implant retained overdenture prosthesis.
Active Comparator: canine group
Patients having two mandibular implants in canine positions
Other: over-denture
implant retained overdenture prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant survival rate
Time Frame: 5 years
index
5 years
circumferential bone loss
Time Frame: 5 years
peri-implant bone changes in mm
5 years
posterior bone changes
Time Frame: 5 years
bone loss in mm
5 years

Collaborators and Investigators

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

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Khloud Ezzat, lecturer

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)

August 23, 2023

Primary Completion (Actual)

October 12, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M0108023RP

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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