Triple-Scan Protocol to Assess Passivity

June 11, 2026 updated by: Alaa mohamed barakat Elazaly, Mansoura University

Triple-Scan Protocol for Evaluating Passivity of Complete-Arch Implant-Supported Fixed Prostheses: A Randomized Clinical Study

Quantification and visualization the internal and marginal gaps by newer digital methods, such as the triple-scan protocol described by Borga Dönmez et al. (2024), employing 3D analysis software, offering a more objective and reproducible assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • 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 Locations

  • Egypt
      • Al Mansurah, Egypt
        • Alaa Mohamed Barakat Elazaly

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Reduced patient satisfaction regarding the stability and retention of conventional mandibular dentures due to mandibular ridge atrophy.

Completely edentulous maxillary and mandibular arches for at least 1 year. Sufficient bone volume for placement of four mandibular implants without the need for bone grafting.

Age between 45 and 64 years. Ability and willingness to provide informed consent and comply with study procedures.

Exclusion Criteria:

Current smoking habit. Bone metabolic diseases that may affect osseointegration. History of radiotherapy to the head and neck region within the previous 3 years.

Systemic conditions or medications that could compromise implant healing. Inability to attend follow-up visits or comply with study requirements.

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequence A

Participants received the three impression techniques in the following order:

Conventional Impression Technique Digital Impression with Nonmodified Scan Body Digital Impression with Modified Scan Body
Device: Conventional Impression Technique
Conventional implant impression using impression copings and elastomeric impression material.
Device: Digital Impression with Nonmodified Scan Body
Digital implant impression obtained using nonmodified implant scan bodies
Device: Digital Impression with Modified Scan Body
Digital implant impression obtained using subtractively modified implant scan bodies
Active Comparator: Sequence B

Participants received the three impression techniques in the following order:

Digital Impression with Nonmodified Scan Body Digital Impression with Modified Scan Body Conventional Impression Technique
Device: Conventional Impression Technique
Conventional implant impression using impression copings and elastomeric impression material.
Device: Digital Impression with Nonmodified Scan Body
Digital implant impression obtained using nonmodified implant scan bodies
Device: Digital Impression with Modified Scan Body
Digital implant impression obtained using subtractively modified implant scan bodies
Active Comparator: Sequence C

Participants received the three impression techniques in the following order:

Digital Impression with Modified Scan Body Conventional Impression Technique Digital Impression with Nonmodified Scan Body
Device: Conventional Impression Technique
Conventional implant impression using impression copings and elastomeric impression material.
Device: Digital Impression with Nonmodified Scan Body
Digital implant impression obtained using nonmodified implant scan bodies
Device: Digital Impression with Modified Scan Body
Digital implant impression obtained using subtractively modified implant scan bodies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean horizontal misfit (µm)
Time Frame: Day 1
Mean horizontal misfit using the triple-scan protocol and STL file superimposition in software. Results will be reported in micrometers (µm).
Day 1
Mean vertical misfit (µm)
Time Frame: Day 1
Mean vertical misfit using the triple-scan protocol and STL file superimposition in software. Results will be reported in micrometers (µm).
Day 1

Collaborators and Investigators

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

Sponsor

Mansoura 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)

April 23, 2023

Primary Completion (Actual)

November 3, 2024

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • R.25.09.24

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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