Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hexed non hexed, non-hexed non-hexed.
- Who it may be relevant to
- Registry conditions: Dental Implant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures: a Randomized Clinical Trial
Overview
This study focuses on the comparison of different implant abutment connections configurations in implant supported screw retained fixed dental prostheses assessing their clinical and radiographic outcomes and to evaluate which implant abutment connection configuration have less biological and technical complications.
Detailed description
Study design:
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.
Interventions
- Device 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. - Device 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
Primary outcome measures
- Marginal Bone Loss [Time frame: Baseline (day of definitive loading) and at 1-year follow-up post-loading.]
Secondary outcome measures (3)
- Technical or mechanical complications [Time frame: 1 year]
- Biological complications [Time frame: 1 year]
- Patient satisfaction [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Adult patients with edentulous span in the posterior mandible of 3 missing teeth.
- 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 edentulous span of less than 3 missing teeth (not eligible to receive a 3 unit 2 implant supported FDP)
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Jordan · 1 center
- Jordan University Hospital — Amman
Identifiers
NCT: NCT06715722 · 10/2024/28042