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NCT05949151 Clinical Trial

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

Occlusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05949151
Other study ID # 14312012023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date May 1, 2023

Study information
Verified date July 2023
Source National Research Centre, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date May 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 55 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• electromyography (EMG) (Nemus II)".
EMG recordings were accomplished by a computer electromyography-based data acquisition system
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.

Locations
Country Name City State
Egypt National Research Centre Cairo Dokki

Sponsors (1)
Lead Sponsor Collaborator
Asmaa Nabil Elboraey

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occlusal equilibrations assessed by Occlusense device Day 1 , one month and 3 month
Primary Muscle activities assessed by Electromyograph (EMG) device Day 1 , one month and 3 month
Secondary oral health-related quality of life (OHRQoL) Oral Health-related Quality of Life questionnaire Day 1, one month and 3 month
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