Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures

Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures: a Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Device: hexed non hexed; Device: non-hexed non-hexed

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad A AL-Rababáh; Phone Number: 00962792131548; Email: malrababah@ju.edu.jo
• Study Contact Backup: Name: Nour G Rababah; Phone Number: 00962791929271; Email: nur.rababah96@gmail.com

Study Locations

• Jordan
  • Amman, Jordan
    • Recruiting
    • Jordan University Hospital
    • Contact: Mohammad A AL-Rababáh; Phone Number: 00962792131548; Email: malrababah@ju.edu.jo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hexed non hexed; a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using hexed and non hexed abutments	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.
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Loss	Marginal bone level changes by standardized periapical radiographs.	Baseline (day of definitive loading) and at 1-year follow-up post-loading.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical or mechanical complications	screw loosening, screw fracture, abutment or implant fracture, prosthesis fracture or chipping	1 year
Biological complications	Peri implant bone loss, early implant failure.	1 year
Patient satisfaction	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.	1 year

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): July 20, 2025
• Study Completion (Estimated): November 10, 2025

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Estimated): December 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Dental implant; Fixed dental prosthesis; Implant abutment connection; Engaging abutment; Non-engaging abutment; Conical connections
• Other Study ID Numbers: 10/2024/28042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No