Triple-Scan Protocol to Assess Passivity

NCT07644689 | Completed

• 1 other identifier: R.25.09.24
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostheses Durability

Outcome Measures

Primary Outcomes (2)

• 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).

  Day 1

• 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).

  Day 1

Study Arms (3)

Sequence A

ACTIVE COMPARATOR

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

Sequence B

ACTIVE COMPARATOR

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

Sequence C

ACTIVE COMPARATOR

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

Digital Impression with Nonmodified Scan Body DEVICE

Digital implant impression obtained using nonmodified implant scan bodies

Sequence A; Sequence B; Sequence C

Digital Impression with Modified Scan Body DEVICE

Digital implant impression obtained using subtractively modified implant scan bodies

Sequence A; Sequence B; Sequence C

Conventional Impression Technique DEVICE

Conventional implant impression using impression copings and elastomeric impression material.

Sequence A; Sequence B; Sequence C

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Alaa Mohamed Barakat Elazaly

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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.

Model Details: Participants underwent all three impression techniques (conventional impression, digital impression with nonmodified scan bodies, and digital impression with modified scan bodies) in a randomized crossover sequence. Each participant served as his or her own control, and the order of impression techniques was randomized to minimize sequence effects.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: June 12, 2026
• Study Start: April 23, 2023
• Primary Completion: November 3, 2024
• Study Completion: February 15, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

EG (1)