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CompletedNCT07644689Updated Jun 12, 2026

Triple-Scan Protocol to Assess Passivity

An interventional study of Conventional Impression Technique and Digital Impression with Nonmodified Scan Body in Prostheses Durability, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 45 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Apr 2023, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
45 Years to 64 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Prostheses Durability
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
18 participants (actual)

Study arms

  • 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 · Device: Digital Impression with Nonmodified Scan Body · Device: Digital Impression with Modified Scan Body

  • 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 · Device: Digital Impression with Nonmodified Scan Body · Device: Digital Impression with Modified Scan Body

  • 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 · Device: Digital Impression with Nonmodified Scan Body · Device: Digital Impression with Modified Scan Body

Interventions

  • DeviceConventional Impression Technique

    Conventional implant impression using impression copings and elastomeric impression material.

  • DeviceDigital Impression with Nonmodified Scan Body

    Digital implant impression obtained using nonmodified implant scan bodies

  • DeviceDigital Impression with Modified Scan Body

    Digital implant impression obtained using subtractively modified implant scan bodies

06

What researchers measure

Primary outcomes

  1. Mean horizontal misfit (µm)

    Mean horizontal misfit using the triple-scan protocol and STL file superimposition in software. Results will be reported in micrometers (µm).

    Time frame: Day 1

  2. Mean vertical misfit (µm)

    Mean vertical misfit using the triple-scan protocol and STL file superimposition in software. Results will be reported in micrometers (µm).

    Time frame: Day 1

07

Study locations

1 site
  • Alaa Mohamed Barakat Elazaly
    Al Mansurah, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07644689
Lead sponsor
Mansoura University
Responsible party
Alaa mohamed barakat Elazaly (Assistant Lecturer of Prosthodontics, Faculty of Dentistry, New Mansoura University, New Mansoura City, Egypt. Postgraduate Student, Department of Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt., Mansoura University) — Principal investigator
First posted
Jun 12, 2026
Start date
Apr 23, 2023
Primary completion
Nov 3, 2024
Completion
Feb 15, 2025
Last update
Jun 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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