Dental Implant
Conditions
Keywords
Implant abutment connection, Dental implant, Fixed dental prosthesis, Engaging abutment, Non-engaging abutment, Conical connections
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.
Interventions
DEVICEhexed 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.
DEVICEnon-hexed non-hexed
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking Description
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Loss | Baseline (day of definitive loading) and at 1-year follow-up post-loading. | Marginal bone level changes by standardized periapical radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 1 year | To be assesses by oral health impact profile-14 (OHIP-14), The scale includes 14 items covering various aspects of oral health-related quality of life, Score Range: from 0 to 56, Higher OHIP-14 scores indicate a worse outcome, representing a greater negative impact of oral health issues on quality of life, while lower scores suggest a better outcome or less impact on the individual's daily life. |
| Technical or mechanical complications | 1 year | screw loosening, screw fracture, abutment or implant fracture, prosthesis fracture or chipping |
| Biological complications | 1 year | Peri implant bone loss, early implant failure. |
Countries
Jordan
Contacts
Primary ContactMohammad A AL-Rababáh
Backup ContactNour G Rababah
Outcome results
None listed