Jordan University Hospital
Amman, Jordan
Location status: Recruiting
NCT Number: NCT06715722
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amman, Jordan
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using one hexed and one non-hexed abutment.
a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments
Time frame: Baseline (day of definitive loading) and at 1-year follow-up post-loading.
Marginal bone level changes by standardized periapical radiographs.
Time frame: 1 year
screw loosening, screw fracture, abutment or implant fracture, prosthesis fracture or chipping
Time frame: 1 year
Peri implant bone loss, early implant failure.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Mohammad A AL-Rababáh
CONTACT
Nour G Rababah
CONTACT
University of Jordan
Other
Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures: a Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07684404
Avitaminosis, Deficiency Diseases
Cairo, New Cairo, Egypt
View Trial DetailsNCT07574606
Atrophic Edentulous Maxilla, Atrophic Maxilla
Cairo, New Cairo, Egypt
View Trial DetailsNCT07551024
Accuracy of Dental Implant Placement, Atrophic Edentulous Maxilla
New Cairo, Cairo Governorate, Egypt
View Trial DetailsNCT06086873
Dental Implant
London, United Kingdom
View Trial Details