Mandibular Implant Overdenture With Bar vs OT Equator: A Randomized Controlled Trial
NCT ID: NCT07121881
Last Updated: 2025-08-14
Study Results
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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NOT_YET_RECRUITING
NA
22 participants
INTERVENTIONAL
2025-09-30
2026-03-31
Brief Summary
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The study compares two options:
A traditional bar attachment
A bar with additional OT Equator attachments, which are designed to improve denture retention and reduce wear
Each participant will receive three implants in the lower jaw, and either a bar attachment alone or a bar with OT Equator attachments will be placed. The goal is to find out which method provides better retention of the denture, causes less bone loss around the implants, has less wear on the attachment parts, and leads to higher patient satisfaction.
Participants will be followed over several months. Their denture retention will be tested using a digital force meter, bone levels will be measured through radiographs, cap wear will be examined using an electron microscope, and satisfaction will be recorded using a questionnaire.
This study is being conducted at Cairo University and is self-funded by the primary investigator. Participation is voluntary and does not involve any financial cost to participants.
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Detailed Description
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A total of 22 completely edentulous participants will be randomly assigned to either group. Each participant will receive three dental implants placed in the anterior mandible. After healing, bar attachments will be fabricated and delivered. In the intervention group, OT Equator attachments will be added to the bar to enhance retention and flexibility. All participants will receive complete upper and lower dentures.
The study's primary outcome is denture retention, measured using a digital force gauge. Secondary outcomes include crestal bone loss (assessed radiographically), cap wear (measured via electron microscopy), and patient satisfaction (evaluated with a Visual Analog Scale questionnaire).
This study will help inform clinical decisions regarding attachment systems for mandibular overdentures and may provide evidence for improved long-term function and patient-reported outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bar Attachment Only
Participants in this group will receive a mandibular implant-assisted overdenture supported by a milled bar attachment only. Three implants will be placed in the anterior mandible (midline and canine regions), and a bar attachment will be fabricated without any additional retentive elements.
Bar Attachment
A bar attachment supported by three mandibular implants (placed in the midline and canine regions) is used to retain a mandibular overdenture. The bar provides rigid splinting across the implants and allows retention using friction or clips, without additional attachment components. This serves as the control group.
Bar with OT Equator Attachment
Participants in this group will receive a mandibular implant-assisted overdenture supported by a milled bar with OT Equator attachments. Three implants will be placed in the anterior mandible (midline and canine regions). Two OT Equator attachments will be incorporated into the bar to enhance retention and stress distribution.
Bar with OT Equator Attachment
A bar attachment supported by three mandibular implants is combined with two OT Equator attachments to enhance denture retention and allow slight vertical and rotational resilience. The OT Equator system includes metal housings and retentive nylon caps, intended to reduce cap wear and improve patient comfort. This is the experimental arm.
Interventions
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Bar Attachment
A bar attachment supported by three mandibular implants (placed in the midline and canine regions) is used to retain a mandibular overdenture. The bar provides rigid splinting across the implants and allows retention using friction or clips, without additional attachment components. This serves as the control group.
Bar with OT Equator Attachment
A bar attachment supported by three mandibular implants is combined with two OT Equator attachments to enhance denture retention and allow slight vertical and rotational resilience. The OT Equator system includes metal housings and retentive nylon caps, intended to reduce cap wear and improve patient comfort. This is the experimental arm.
Eligibility Criteria
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Inclusion Criteria
* Age between 35 and 65 years.
* Sufficient bone in the anterior and premolar-molar regions (≥11 mm).
* Adequate inter-arch space (12-14 mm).
Exclusion Criteria
* Presence of parafunctional habits such as clenching or bruxism.
* Temporomandibular joint disorders.
* Smokers.
* History of drug abuse.
* History of head and neck radiation.
* Systemic disorders that could prevent surgery or affect bone quality (e.g., uncontrolled diabetes, osteoporosis).
35 Years
65 Years
ALL
Yes
Sponsors
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Hala Abdel salam Selim
OTHER
Responsible Party
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Hala Abdel salam Selim
PhD Candidate
Principal Investigators
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Hamdy Abo EL-Fotouh, Professor
Role: STUDY_CHAIR
Faculty of Oral and Dental Medicine, Cairo University
Noha Ali, asso. Professor
Role: STUDY_DIRECTOR
Faculty of Oral and Dental Medicine, Cairo University
Ahmed Hamed, Lecturer
Role: STUDY_DIRECTOR
Faculty of Oral and Dental Medicine, Cairo University
Locations
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Faculty of Oral and Dental Medicine, Cairo University
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS-OTBarRCT2024
Identifier Type: -
Identifier Source: org_study_id
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