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Completed

NCT Number: NCT05402202

Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations

The aim of this randomized clinical trial is to evaluate the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

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Key information

Conditions

Dental Implants, Single-tooth

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

About this study

Evaluation of the clinical performance through prosthodontic, periodontal and radiographic evaluation of single screw-retained implant-supported restorations fabricated by intraoral scanning of healing abutment with scan peg in comparison to scan body

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:
  • Adequate interarch and mesiodistal space.
  • Proper bone height and width.
  • Adequate zone of keratinized tissue (at least 2 mm)

Exclusion criteria

  • Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases
  • A history of head and neck radiation treatment.
  • Periodontal diseases.
  • Poor oral hygiene (Silness-Löe plaque index score 2 and 3) (32)
  • Parafunctional habits.
  • Malocclusion.

Treatment and study plan

Healing abutment with scan peg (Neoss implant system, Harrogate, England)

Other

12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg

Customized healing abutment

Other

12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment fabricated by intraoral scanning by scan body

Primary outcomes

  1. Scanning time (healing abutment-scan peg vs scan body)

    Time frame: Through study completion, an average of 1 year

    The scanning time by intraoral scanner will be recorded in both groups

  2. Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body

    Time frame: Through study completion, an average of 1 year

    The proximal contacts will be evaluated with dental floss

    • Open: an open contact will be reported if there is no resistance against floss
    • Ideal: an ideal contact will be reported if there is some resistance to interproximal floss insertion.
    • Tight: a tight contact will be reported if it prevents the passage of floss through the proximal contact point.

    The percentage of proximal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.

  3. Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body

    Time frame: Through study completion, an average of 1 year

    An evaluation of occlusion will be executed with 2 layers of shim stock of 12µ.

    • No adjustment: if the shimstock is held when the patient clenches and does not need any adjustment.
    • Mild adjustment: If the shim stock is held after simple closure, the occlusal contact will be reported as heavy and received mild chairside adjustment.
    • Major adjustment: If the crown is returned to the manufacturing technician, the adjustment is considered major.
    • Out of occlusion: If the shim stock passes without resistance after clenching, an open contact will be reported.

    The percentage of occlusal contacts will be calculated for each group at day of crown delivery, 3 months and 6 months later.

  4. Evaluation of occlusion by digital occlusal analyzer

    Time frame: Through study completion, an average of 1 year

    occlusal force of implant-supported restorations will be measured

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 2, 2022
Registry last updated
Feb 25, 2025

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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