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

NCT ID: NCT05949151

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Occlusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
the investigator didn't know which patients belonged to which group

Study Groups

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Group I

Patients received a complete removable mandibular implant supported overdenture

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Six dental implants inserted on the edentulous mandible

Occlusense (Bausch GmbH & Co. KG)

Intervention Type DEVICE

sensor used to evaluate the equilibration of occlusal forces.

electromyography (EMG) (Nemus II)".

Intervention Type DEVICE

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

oral health-related quality of life (OHRQoL)

Intervention Type 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.

Group II

Patients received implant supported fixed bridge

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Six dental implants inserted on the edentulous mandible

Occlusense (Bausch GmbH & Co. KG)

Intervention Type DEVICE

sensor used to evaluate the equilibration of occlusal forces.

electromyography (EMG) (Nemus II)".

Intervention Type DEVICE

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

oral health-related quality of life (OHRQoL)

Intervention Type 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.

Interventions

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

Six dental implants inserted on the edentulous mandible

Intervention Type PROCEDURE

Occlusense (Bausch GmbH & Co. KG)

sensor used to evaluate the equilibration of occlusal forces.

Intervention Type DEVICE

electromyography (EMG) (Nemus II)".

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

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Assessment of Muscle Activity by electromyography (EMG) (Nemus II)

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Asmaa Nabil Elboraey

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Nabil Elboraey

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Asmaa Elboraey, Ass.Prof

Role: PRINCIPAL_INVESTIGATOR

National Research Centre, Egypt

Locations

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National Research Centre

Cairo, Dokki, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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14312012023

Identifier Type: -

Identifier Source: org_study_id

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