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

Sponsor
Asmaa Nabil Elboraey (Other)
Overall Status
Completed
CT.gov ID
NCT05949151
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
3.9
Actual Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: dental implants (K1 line conical connection double thread, OXY, Italy)
  • Device: Occlusense (Bausch GmbH & Co. KG)
  • Device: electromyography (EMG) (Nemus II)".
  • Other: oral health-related quality of life (OHRQoL)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
Masking:
Single (Outcomes Assessor)
Masking Description:
the investigator didn't know which patients belonged to which group
Primary Purpose:
Treatment
Official Title:
Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Mar 1, 2023
Actual Study Completion Date :
May 1, 2023

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Occlusal equilibrations [Day 1 , one month and 3 month]

      assessed by Occlusense device

    2. Muscle activities [Day 1 , one month and 3 month]

      assessed by Electromyograph (EMG) device

    Secondary Outcome Measures

    1. oral health-related quality of life (OHRQoL) [Day 1, one month and 3 month]

      Oral Health-related Quality of Life questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Research Centre Cairo Dokki Egypt 12622

    Sponsors and Collaborators

    • Asmaa Nabil Elboraey

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asmaa Nabil Elboraey, Associate Professor, National Research Centre, Egypt
    ClinicalTrials.gov Identifier:
    NCT05949151
    Other Study ID Numbers:
    • 14312012023
    First Posted:
    Jul 17, 2023
    Last Update Posted:
    Jul 17, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Asmaa Nabil Elboraey, Associate Professor, National Research Centre, Egypt
    implant supported overdenture
    muscle activity

    Study Results

    No Results Posted as of Jul 17, 2023