Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures
NCT ID: NCT06715722
Last Updated: 2024-12-04
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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RECRUITING
NA
24 participants
INTERVENTIONAL
2024-11-11
2025-11-10
Brief Summary
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Detailed Description
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This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.
The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, patients who will receive 2 internal connection dental implants to replace 3 posterior missing teeth in the mandible with a 3 unit screw-retained FDP with sufficient bone volume and controlled oral hygiene. The intervention group will receive a screw-retained FDP with conical engaging and non engaging abutment configuration, while the comparator group will a screw-retained FDP with both conical non engaging abutment configuration. The primary outcome is changes in marginal bone levels, and the secondary outcomes include technical and mechanical complications, biological complications, and patient satisfaction.
Both groups will receive 2 internal connection implants in the posterior mandible in healed sites of at least 3 months (guided implant surgery). The surgical procedure will follow standardized protocols, with no variations between groups other than the types of implant abutment connections used.
Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: definitive loading, after 6 months of loading, after 2 years loading.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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hexed non hexed
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using hexed and non hexed abutments
hexed non hexed
A 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using one hexed and one non-hexed abutment.
non hexed non hexed
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments
non-hexed non-hexed
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments
Interventions
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hexed non hexed
A 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using one hexed and one non-hexed abutment.
non-hexed non-hexed
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments
Eligibility Criteria
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Inclusion Criteria
* Candidates for an implant supported FDP in the posterior mandible.
* Teeth in area of interest extracted at least 3 months prior.
* Bone grafting not needed or only minor GBR needed.
* Controlled oral hygiene.
* Sufficient bone volume.
Exclusion Criteria
* Patients with healing period of extraction sites less than 3 months.
* Extensive bone grafting required prior to or during implant placement.
* Active Bruxism.
* Heavy smoker (\> 10 cigarettes).
* Systemic diseases that might affect bone healing.
* Patients who are not willing or unable to give consent.
18 Years
ALL
Yes
Sponsors
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University of Jordan
OTHER
Responsible Party
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Mohammad AL-Rababáh
Associate Professor
Locations
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Jordan University Hospital
Amman, , Jordan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10/2024/28042
Identifier Type: -
Identifier Source: org_study_id