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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05949151
Enrollment
22
Registered
2023-07-17
Start date
2023-01-01
Completion date
2023-05-01
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occlusion

Keywords

implant supported overdenture, muscle activity

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.

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.

Interventions

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

Six dental implants inserted on the edentulous mandible

DEVICEOcclusense (Bausch GmbH & Co. KG)

sensor used to evaluate the equilibration of occlusal forces.

DEVICEelectromyography (EMG) (Nemus II).

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

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.

Sponsors

Asmaa Nabil Elboraey
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
55 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Occlusal equilibrationsDay 1 , one month and 3 monthassessed by Occlusense device
Muscle activitiesDay 1 , one month and 3 monthassessed by Electromyograph (EMG) device

Secondary

MeasureTime frameDescription
oral health-related quality of life (OHRQoL)Day 1, one month and 3 monthOral Health-related Quality of Life questionnaire

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026