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Clinical Trials/NCT05402202
NCT05402202
Completed
N/A

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

Alexandria University1 site in 1 country24 target enrollmentMay 10, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dental Implants, Single-Tooth
Sponsor
Alexandria University
Enrollment
24
Locations
1
Primary Endpoint
Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
May 10, 2022
End Date
November 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rania Elsayed

Assistant Lecturer, Department of Prosthodontics, Faculty of Dentistry

Alexandria University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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 1. Open: an open contact will be reported if there is no resistance against floss 2. Ideal: an ideal contact will be reported if there is some resistance to interproximal floss insertion. 3. 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.

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

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

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. 1. No adjustment: if the shimstock is held when the patient clenches and does not need any adjustment. 2. Mild adjustment: If the shim stock is held after simple closure, the occlusal contact will be reported as heavy and received mild chairside adjustment. 3. Major adjustment: If the crown is returned to the manufacturing technician, the adjustment is considered major. 4. 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.

Study Sites (1)

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