Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture

July 14, 2023 updated by: Asmaa Nabil Elboraey

22 Patients having lower completely edentulous mandible aged 55-60 years were selected from the outpatient dental clinic of the Medical Excellence Centre of the National Research (NRC) Cairo, Egypt. Six dental implants were inserted in the mandible of each patient.

The patients were randomly categorized into two groups according to the final restoration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.

Occlusal equilibrations, Muscle activities, and oral health-related quality of life (OHRQoL) were assessed by at the time of prosthesis insertion, after one and three month.

Study Type

Interventional

Enrollment (Actual)

22

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:

  • edentulous mandible with well-developed alveolar ridge
  • free from temporomandibular joint disorder
  • free from any chronic diseases.

Exclusion Criteria:

  • smoker
  • patients having systemically immunosuppressive diseases
  • patients receiving radiotherapy.

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 a complete removable mandibular implant supported overdenture
Procedure: dental implants (K1 line conical connection double thread, OXY, Italy)
Six dental implants inserted on the edentulous mandible
Device: Occlusense (Bausch GmbH & Co. KG)
sensor used to evaluate the equilibration of occlusal forces.
Device: electromyography (EMG) (Nemus II)".
EMG recordings were accomplished by a computer electromyography-based data acquisition system
Other Names:
  • Assessment of Muscle Activity by electromyography (EMG) (Nemus II)
Other: oral health-related quality of life (OHRQoL)
Oral Health-related Quality of Life (OHRQoL) was estimated by employing the Oral Health Impact Profile questionnaire which comprises nineteen multiple questions that were translated into Arabic.
Active Comparator: Group II
Patients received implant supported fixed bridge
Procedure: dental implants (K1 line conical connection double thread, OXY, Italy)
Six dental implants inserted on the edentulous mandible
Device: Occlusense (Bausch GmbH & Co. KG)
sensor used to evaluate the equilibration of occlusal forces.
Device: electromyography (EMG) (Nemus II)".
EMG recordings were accomplished by a computer electromyography-based data acquisition system
Other Names:
  • Assessment of Muscle Activity by electromyography (EMG) (Nemus II)
Other: oral health-related quality of life (OHRQoL)
Oral Health-related Quality of Life (OHRQoL) was estimated by employing the Oral Health Impact Profile questionnaire which comprises nineteen multiple questions that were translated into Arabic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal equilibrations
Time Frame: Day 1 , one month and 3 month
assessed by Occlusense device
Day 1 , one month and 3 month
Muscle activities
Time Frame: Day 1 , one month and 3 month
assessed by Electromyograph (EMG) device
Day 1 , one month and 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oral health-related quality of life (OHRQoL)
Time Frame: Day 1, one month and 3 month
Oral Health-related Quality of Life questionnaire
Day 1, one month and 3 month

Collaborators and Investigators

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

Sponsor

Asmaa Nabil Elboraey

Investigators

  • Principal Investigator: Asmaa Elboraey, Ass.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)

January 1, 2023

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14312012023

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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