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

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Implants, Single-Tooth
• Intervention / Treatment: Other: Healing abutment with scan peg (Neoss implant system, Harrogate, England); Other: Customized healing abutment

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 Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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
Active Comparator: Customized healing abutment; 12 participants will receive Neoss implants by fully-guided implant protocol followed by placement of customized healing abutment	Other: Customized healing abutment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; 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.	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.; 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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant Probing Depth (scan peg vs customized healing abutment)	Peri-implant probing depth refers to the distance from the gingival margin till the point of least resistance. The peri-implant probing depth will be measured using a graduated plastic autoclavable periodontal probe. The probe will be held parallel to the long axis of the implant and introduced with light force to the peri-implant sulcus. Measurements will be made at 4 sites around each implant; mesiobuccal, disto-buccal, mesio-palatal and disto-palatal. Probing depth of 1 mm or less will be recorded as 1 mm, and those exceeding 1 mm, but less than 2 mm, will be recorded as 2 mm, and so on. The mean for each implant will be calculated.	up to 6 months
Clinical Attachment level (scan peg vs customized healing abutment)	It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level will be performed simultaneously while measuring the peri-implant probing depth.	up to 6 months
Modified gingival index (scan peg vs customized healing abutment)	The peri-implant mucosal tissues around the implants will be assessed according to Lobene and Weatherford. The category criteria for assessment will be as follows: 0: Absence of inflammation, normal gingiva.; Mild inflammation, slight color change, little change in texture of any portion of, but not entire, marginal, or papillary gingival unit (localized).; Mild inflammation, slight color change, little change in texture involving the entire or papillary gingival unit (generalized).; Moderate inflammation, redness, and edema.; Severe inflammation, marked redness, edema, ulceration, and spontaneous bleeding It will be measured at 4 sites around each implant (mesially, distally, labially/ buccaly, lingually) then, the mean record will be calculated for each implant.	up to 6 months
Marginal bone loss (scan peg vs customized healing abutment)	Periapical digital radiographs will be taken at time of crown insertion (baseline) and up to 6 months later. Changes in the marginal bone level will be evaluated every time using standardized radiographs. To achieve the same orthoradial perspective on the implants, X-ray film positioning devices will be used. After importing screenshots of the radiographs, the amount of bone loss will be measured.	up to 6 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): November 10, 2023
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IORG0008831

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No