Prostheses DurabilityNCT07644689
Triple-Scan Protocol to Assess Passivity
A study testing Conventional Impression Technique, Digital Impression with Nonmodified Scan Body and Digital Impression with Modified Scan Body in people with Prostheses Durability, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostheses Durability
- What is being tested?
- Conventional Impression Technique, Digital Impression with Nonmodified Scan Body and Digital Impression with Modified Scan Body
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Apr 2023to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prostheses Durability
- Being tested
- Conventional Impression Technique, Digital Impression with Nonmodified Scan Body, Digital Impression with Modified Scan Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Impression TechniqueDevice
Conventional implant impression using impression copings and elastomeric impression material.
Digital Impression with Nonmodified Scan BodyDevice
Digital implant impression obtained using nonmodified implant scan bodies
Digital Impression with Modified Scan BodyDevice
Digital implant impression obtained using subtractively modified implant scan bodies
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Conventional Impression Technique; Device: Digital Impression with Nonmodified Scan Body; Device: Digital Impression with Modified Scan Body |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start23 Apr 2023
- Primary completion3 Nov 2024
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostheses DurabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa mohamed barakat Elazaly, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644689
- Sponsor's protocol ID
- R.25.09.24
- Status last verified
- Jun 2026
- First submitted
- 25 Nov 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-Scan Protocol for Evaluating Passivity of Complete-Arch Implant-Supported Fixed Prostheses: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07644689
- Acronym / sponsor ID
- R.25.09.24
- Conditions
- Prostheses Durability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 3 Nov 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Active comparator | Device: Conventional Impression Technique, Device: Digital Impression with Nonmodified Scan Body, Device: Digital Impression with Modified Scan BodyParticipants received the three impression techniques in the following order: Conventional Impression Technique Digital Impression with Nonmodified Scan Body Digital Impression with Modified Scan Body |
| Sequence B | Active comparator | Device: Conventional Impression Technique, Device: Digital Impression with Nonmodified Scan Body, Device: Digital Impression with Modified Scan BodyParticipants received the three impression techniques in the following order: Digital Impression with Nonmodified Scan Body Digital Impression with Modified Scan Body Conventional Impression Technique |
| Sequence C | Active comparator | Device: Conventional Impression Technique, Device: Digital Impression with Nonmodified Scan Body, Device: Digital Impression with Modified Scan BodyParticipants received the three impression techniques in the following order: Digital Impression with Modified Scan Body Conventional Impression Technique Digital Impression with Nonmodified Scan Body |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Impression TechniqueConventional implant impression using impression copings and elastomeric impression material. | Device | Sequence A, Sequence B, Sequence C |
| Digital Impression with Nonmodified Scan BodyDigital implant impression obtained using nonmodified implant scan bodies | Device | Sequence A, Sequence B, Sequence C |
| Digital Impression with Modified Scan BodyDigital implant impression obtained using subtractively modified implant scan bodies | Device | Sequence A, Sequence B, Sequence C |
Primary outcome
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Impression Technique, Digital Impression with Nonmodified Scan Body and Digital Impression with Modified Scan Body in people with Prostheses Durability, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean horizontal misfit (µm) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.