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

Not Applicable

Completed

• Conditions: Dental Implants, Single-Tooth
• Interventions: Other: Healing abutment with scan peg (Neoss implant system, Harrogate, England); Other: Customized healing abutment

• Registration Number: NCT05402202
• Lead Sponsor: Alexandria University

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

Study Timeline

• Study Start: 2022-05-10
• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-02
• Primary Completion: 2023-11-10
• Study Completion: 2024-11-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-22
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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:

  1. Adequate interarch and mesiodistal space.
  2. Proper bone height and width.
  3. Adequate zone of keratinized tissue (at least 2 mm)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healing abutment with scan peg (Neoss implant system, Harrogate, England)	Healing abutment with scan peg (Neoss implant system, Harrogate, England)	12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg
Customized healing abutment	Customized healing abutment	12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment

Primary Outcome Measures

Name	Time	Method
Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body	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)	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	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	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt