Clinical Performance and Accuracy of Healing Abutment With Scan Peg for Single Posterior Implant-supported Restorations
1 other identifier
interventional
24
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2022
CompletedFirst Submitted
Initial submission to the registry
May 30, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedFebruary 25, 2025
February 1, 2025
1.5 years
May 30, 2022
February 22, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Scanning time (healing abutment-scan peg vs scan body)
The scanning time by intraoral scanner will be recorded in both groups
Through study completion, an average of 1 year
Quality of proximal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
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.
Through study completion, an average of 1 year
Quality of occlusal contacts of crowns fabricated by intraoral scanning of scan peg vs scan body
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.
Through study completion, an average of 1 year
Evaluation of occlusion by digital occlusal analyzer
occlusal force of implant-supported restorations will be measured
Through study completion, an average of 1 year
Study Arms (2)
Healing abutment with scan peg (Neoss implant system, Harrogate, England)
EXPERIMENTAL12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg
Customized healing abutment
ACTIVE COMPARATOR12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment
Interventions
12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of healing abutment with scan peg
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, 21527, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer, Department of Prosthodontics, Faculty of Dentistry
Study Record Dates
First Submitted
May 30, 2022
First Posted
June 2, 2022
Study Start
May 10, 2022
Primary Completion
November 10, 2023
Study Completion
November 1, 2024
Last Updated
February 25, 2025
Record last verified: 2025-02