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NCT Number: NCT06715722

Comparison of Abutments Engagement Configurations in Implant Supported Fixed Partial Dentures

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hexed non hexed

Device

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

non-hexed non-hexed

Device

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

Primary outcomes

  1. Marginal Bone Loss

    Time frame: Baseline (day of definitive loading) and at 1-year follow-up post-loading.

    Marginal bone level changes by standardized periapical radiographs.

Secondary outcomes

  1. Technical or mechanical complications

    Time frame: 1 year

    screw loosening, screw fracture, abutment or implant fracture, prosthesis fracture or chipping

  2. Biological complications

    Time frame: 1 year

    Peri implant bone loss, early implant failure.

  3. Patient satisfaction

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad A AL-Rababáh

CONTACT

[email protected]

00962792131548

Nour G Rababah

CONTACT

[email protected]

00962791929271

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

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.

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