Clinical Performance and Stability of Different Types of Implant Supported Overdenture

July 25, 2023 updated by: Asmaa Nabil Elboraey, National Research Centre, Egypt

A Total number of 36 implants were installed in 6 patients having mandibular single denture.

The patients were divided into two groups according to the definitive prosthesis.

Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Implant's stability, clinical performance (gingival index, pocket depth, plaque index and bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days after prosthesis delivery

Study Type

Interventional

Enrollment (Actual)

6

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
    • Dokki
      • Cairo, Dokki, Egypt, 12622
        • National Research Centre

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • highly co-operative
  • non-smoker
  • systemically free from any chronic diseases

Exclusion Criteria:

  • immunocompromised patients
  • patients having knife edge, flat or flabby ridge,
  • patients having T. M. J disorders

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 received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible.
Device: Osstell ( Osstell AB, Goteborg, Sweden).
Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery
Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein
Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery
Other Names:
  • - Assessment of implants clinical performance
Other: questionnaire for patient satisfaction
A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.
Experimental: Group II
patients received cement retained mandibular implant overdentures restoring complete edentulous mandible.
Device: Osstell ( Osstell AB, Goteborg, Sweden).
Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery
Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein
Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery
Other Names:
  • - Assessment of implants clinical performance
Other: questionnaire for patient satisfaction
A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of change in implant stability
Time Frame: on the 15th, 30th, 60th and 90th days of overdenture insertion
Assessment of implant stability by device ( Ostell device)
on the 15th, 30th, 60th and 90th days of overdenture insertion
Assessment of change in implants clinical performance throughout the follow-up period.
Time Frame: on the 15th, 30th, 60th and 90th days of over denture insertion.
Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe.
on the 15th, 30th, 60th and 90th days of over denture insertion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of patient satisfaction
Time Frame: on the 90th day of prosthesis delivery
A questionnaire was used to evaluate patient satisfaction
on the 90th day of prosthesis delivery

Collaborators and Investigators

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

Sponsor

National Research Centre, Egypt

Investigators

  • Principal Investigator: Asmaa N. Elboraey, Asso, Prof, National Research Centre, Egypt

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 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 5, 2023

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 64312012023

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.

Clinical Trials on Complete Edentulism

Clinical Trials on Osstell ( Osstell AB, Goteborg, Sweden).

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe