Clinical trial NCT06715722: Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures
Official title: Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Keywords: Implant abutment connection
Dental implant
Fixed dental prosthesis
Engaging abutment
Non-engaging abutment
Conical connections
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Marginal Bone Loss
timeFrame: Baseline (day of definitive loading) and at 1-year follow-up post-loading.
Secondary outcomes:
measure: Technical or mechanical complications
timeFrame: 1 year
measure: Biological complications
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References: