Occlusal Forces and Muscle Activity in Fixed Versus Removable Mandibular Implant Supported Overdenture
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
June 30, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedJuly 17, 2023
July 1, 2023
2 months
June 30, 2023
July 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
oral health-related quality of life (OHRQoL)
Day 1, one month and 3 month
Study Arms (2)
Group I
ACTIVE COMPARATORPatients received a complete removable mandibular implant supported overdenture
Group II
ACTIVE COMPARATORPatients received implant supported fixed bridge
Interventions
Six dental implants inserted on the edentulous mandible
sensor used to evaluate the equilibration of occlusal forces.
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.
Eligibility Criteria
You may qualify if:
- edentulous mandible with well-developed alveolar ridge
- free from temporomandibular joint disorder
- free from any chronic diseases.
You may not qualify if:
- smoker
- patients having systemically immunosuppressive diseases
- patients receiving radiotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Research Centre
Cairo, Dokki, 12622, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asmaa Elboraey, Ass.Prof
National Research Centre, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- the investigator didn't know which patients belonged to which group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 30, 2023
First Posted
July 17, 2023
Study Start
January 1, 2023
Primary Completion
March 1, 2023
Study Completion
May 1, 2023
Last Updated
July 17, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share