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

Study Overview
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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.

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

Conditions
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Occlusion

Intervention / Treatment
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* 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)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two group Group I: received a complete removable mandibular implant supported overdenture. While Group II: received implant supported fixed bridge.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>Patients received a complete removable mandibular implant supported overdenture | Procedure: dental implants (K1 line conical connection double thread, OXY, Italy)<br>* Six dental implants inserted on the edentulous mandible<br>Device: Occlusense (Bausch GmbH & Co. KG)<br>* sensor used to evaluate the equilibration of occlusal forces.<br>Device: electromyography (EMG) (Nemus II).<br>* EMG recordings were accomplished by a computer electromyography-based data acquisition system<br>* Other names: Assessment of Muscle Activity by electromyography (EMG) (Nemus II);Other: oral health-related quality of life (OHRQoL)<br>* 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.<br>|
| Active Comparator: Group II<br>Patients received implant supported fixed bridge | Procedure: dental implants (K1 line conical connection double thread, OXY, Italy)<br>* Six dental implants inserted on the edentulous mandible<br>Device: Occlusense (Bausch GmbH & Co. KG)<br>* sensor used to evaluate the equilibration of occlusal forces.<br>Device: electromyography (EMG) (Nemus II).<br>* EMG recordings were accomplished by a computer electromyography-based data acquisition system<br>* Other names: Assessment of Muscle Activity by electromyography (EMG) (Nemus II);Other: oral health-related quality of life (OHRQoL)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusal equilibrations | assessed by Occlusense device | Day 1 , one month and 3 month | 
| Muscle activities | 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) | Oral Health-related Quality of Life questionnaire | Day 1, one month and 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implant supported overdenture, muscle activity