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OpenTrials
Completed

NCT Number: NCT07644689

Triple-Scan Protocol to Assess Passivity

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.

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Key information

Conditions

Prostheses Durability

Age range

45 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alaa Mohamed Barakat Elazaly

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Impression Technique

Device

Conventional implant impression using impression copings and elastomeric impression material.

Digital Impression with Nonmodified Scan Body

Device

Digital implant impression obtained using nonmodified implant scan bodies

Digital Impression with Modified Scan Body

Device

Digital implant impression obtained using subtractively modified implant scan bodies

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.