Actively Recruiting
Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures: a Randomized Clinical Trial
Led by University of Jordan · Updated on 2024-12-04
24
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating different implant abutment connection configurations in implant-supported screw-retained fixed dental prostheses. The study aims to compare clinical and radiographic outcomes to determine which abutment connection results in fewer biological and technical complications. This randomized controlled trial involves patients aged 18 years or older receiving dental implants for missing teeth in the posterior mandible. Participants will be randomly assigned to one of two groups: one receiving a 3-unit screw-retained implant bridge supported by one hexed and one non-hexed abutment, and the other receiving a similar bridge supported by two non-hexed abutments. Both groups will receive two internal connection implants placed in healed sites with a minimum healing period of three months. The surgical procedure will follow standardized protocols, differing only by the abutment connection configuration. Participants will undergo clinical and radiographic evaluations at the time of definitive loading, six months after loading, and two years after loading. Researchers will measure changes in marginal bone levels as the primary outcome, with secondary outcomes including technical and mechanical complications, biological complications, and patient satisfaction. The study includes a one-year follow-up period for assessing these outcomes.
CONDITIONS
Brief Title
Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with edentulous span in the posterior mandible of 3 missing teeth.
- Candidates for an implant supported fixed dental prosthesis in the posterior mandible.
- Teeth in the area of interest extracted at least 3 months prior.
- Bone grafting not needed or only minor guided bone regeneration needed.
- Controlled oral hygiene.
- Sufficient bone volume.
You will not qualify if you...
- Patients with edentulous span of less than 3 missing teeth (not eligible to receive a 3-unit 2 implant supported fixed dental prosthesis).
- Patients with healing period of extraction sites less than 3 months.
- Extensive bone grafting required prior to or during implant placement.
- Active bruxism (teeth grinding).
- Heavy smoker (more than 10 cigarettes per day).
- Systemic diseases that might affect bone healing.
- Patients who are not willing or unable to give consent.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants receive two internal connection dental implants in the posterior mandible following standardized surgical protocols.
1 visit (in-person) for implant placement
Duration - Definitive loading day until 1 year post-loading
Participants receive a 3-unit screw-retained fixed dental prosthesis with either a hexed and non-hexed abutment configuration or two non-hexed abutments.
1 baseline visit on the day of definitive loading
Duration - 1 year post-loading
Participants attend follow-up visits for clinical and radiographic evaluations to assess marginal bone levels, complications, and satisfaction.
3 follow-up visits: at definitive loading, 6 months, and 1 year post-loading
Trial Site Locations
Total: 1 location
1
Jordan University Hospital
Amman, Jordan
Actively Recruiting
Research Team
M
Mohammad A AL-Rababáh
N
Nour G Rababah
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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