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

February 22, 2025 updated by: Rania Elsayed, Alexandria University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21527
        • Faculty of dentistry, Alexandria university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peri-implant Probing Depth (scan peg vs customized healing abutment)
Time Frame: up to 6 months

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)
Time Frame: up to 6 months
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)
Time Frame: up to 6 months

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.

  1. Mild inflammation, slight color change, little change in texture of any portion of, but not entire, marginal, or papillary gingival unit (localized).
  2. Mild inflammation, slight color change, little change in texture involving the entire or papillary gingival unit (generalized).
  3. Moderate inflammation, redness, and edema.
  4. 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)
Time Frame: up to 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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