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Triple-Scan Protocol to Assess Passivity

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07644689
Enrollment
18
Registered
2026-06-12
Start date
2023-04-23
Completion date
2025-02-15
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostheses Durability

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.

Interventions

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
45 Years to 64 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean horizontal misfit (µm)Day 1Mean horizontal misfit using the triple-scan protocol and STL file superimposition in software. Results will be reported in micrometers (µm).
Mean vertical misfit (µm)Day 1Mean vertical misfit using the triple-scan protocol and STL file superimposition in software. Results will be reported in micrometers (µm).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026