NCT06715722

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

Keywords

Implant abutment connectionDental implantFixed dental prosthesisEngaging abutmentNon-engaging abutmentConical connections

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Technical or mechanical complications

    1 year

  • Biological complications

    1 year

  • Patient satisfaction

    1 year

Study Arms (2)

hexed non hexed

EXPERIMENTAL

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

non hexed non hexed

ACTIVE COMPARATOR

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

Interventions

A 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using one hexed and one non-hexed abutment.

hexed non hexed

a 3-unit screw-retained implant bridge over two conical internal hex implants will be supported using two non-hexed abutments

non hexed non hexed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University Hospital

Amman, Jordan

RECRUITING

Central Study Contacts

Mohammad A AL-Rababáh

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking Description
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 4, 2024

Study Start

November 11, 2024

Primary Completion

July 20, 2025

Study Completion

November 10, 2025

Last Updated

December 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations