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OpenTrials
Completed

NCT Number: NCT05949151

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

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.

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Key information

Conditions

Occlusion Bites and Stings Chemically-Induced Disorders Poisoning Wounds and Injuries

Age range

55 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Cairo, Dokki, 12622, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dental implants (K1 line conical connection double thread, OXY, Italy)

Procedure

Six dental implants inserted on the edentulous mandible

Occlusense (Bausch GmbH & Co. KG)

Device

sensor used to evaluate the equilibration of occlusal forces.

electromyography (EMG) (Nemus II)".

Device

EMG recordings were accomplished by a computer electromyography-based data acquisition system

Other names: Assessment of Muscle Activity by electromyography (EMG) (Nemus II)

oral health-related quality of life (OHRQoL)

Other

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.

Primary outcomes

  1. Occlusal equilibrations

    Time frame: Day 1 , one month and 3 month

    assessed by Occlusense device

  2. Muscle activities

    Time frame: Day 1 , one month and 3 month

    assessed by Electromyograph (EMG) device

Secondary outcomes

  1. oral health-related quality of life (OHRQoL)

    Time frame: Day 1, one month and 3 month

    Oral Health-related Quality of Life questionnaire

Sponsors and collaborators

Lead sponsor

Asmaa Nabil Elboraey

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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