Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture

October 25, 2023 updated by: Mansoura University

A Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant-supported Overdenture; A 3-year Radiographic and Clinical Follow-up Study

This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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, P.O.Box:35516
        • Mansoura University ,Faculty of dentistry

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:

  • 1. All selected patients have two implants placed in the mandibular interforaminal region.

    2. All selected patients have a healthy mucosa and with no clinical complications.

    3. All patients are cooperative and approve the proposed treatment protocol

Exclusion Criteria:

  • 1. Patients who reject to participate in the study. 2.Patients who need implant placement as a result of previous implant failure

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I
patients who would be delivered a mandibular implant overdenture using conventional locator attachments.
Procedure: implant supported overdenture
patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments
Active Comparator: Group II (study)
patients who would be delivered mandibular implant overdenture using Locator RTX attachments
Procedure: implant supported overdenture
patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
crestal cone loss
Time Frame: three years
Intraoral radiographs were performed using the long cone paralleling technique to evaluate crestal bone loss
three years
prosthetic complications
Time Frame: three years
prosthetic complications were scored clinically
three years

Collaborators and Investigators

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

Sponsor

Mansoura University

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)

February 16, 2020

Primary Completion (Actual)

June 7, 2022

Study Completion (Actual)

September 16, 2023

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • A0208023RP

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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