Effect of Geometric Modifications of Implant Scan Bodies

NCT ID: NCT06040385

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2025-02-16

Brief Summary

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The aim of this clinical study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations

Detailed Description

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The aim of this study will be the effect of geometric modifications of implant scan bodies compared to conventional transfer techniques on passivity of all on four mandibular restorations.

Evaluation method:

The trueness of the final impression and the passivity of the final prosthesis will be evaluated by two methods:

Invitro evaluation For each patient in every group, the standard tessellation language (STL) files of scanned impressions will be superimposed on the reference file to determine the 3D surface, linear, and angular position analysis.

The STL files for both frameworks will be superimposed on the reference file to determine the passivity.

In vivo (Clinical) evaluation Radiographic evaluation using long cone parallel technique will be done for the framework after 6 month (T6) after one year (T12), and after 18 month (T18) from insertion.

Conditions

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Prosthesis Durability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

For group (I):

For each patient, two final impressions will be made a) Final impression will be done by conventional one-step impression technique.For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique.

For group (II):

For each patient, two final impressions will be made

a) Final impression will be done by conventional one-step impression technique.For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique.

Conventional impression for both groups will be poured into stone cast with multiunit abutments analogues, then scanned to be as a reference file for each patient.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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• Group I (control group)

Final impression will be done by conventional one-step impression technique. For the same patient, another final impression using unmodified scan bodies will be done by direct intraoral scan technique.

Group Type ACTIVE_COMPARATOR

Implant supported hybrid prosthesis

Intervention Type DEVICE

For each patient, implant supported mandibular hybrid prosthesis will be fabricated digitally. Frameworks will be tried in patient's mouth, scanned intraorally by intraoral scanner (IOS).

• Group II (Test Group)

Final impression will be done by conventional one-step impression technique. For the same patient another final impression using subtractive modified scan bodies will be done by direct intraoral scan technique

Group Type ACTIVE_COMPARATOR

Implant supported hybrid prosthesis

Intervention Type DEVICE

For each patient, implant supported mandibular hybrid prosthesis will be fabricated digitally. Frameworks will be tried in patient's mouth, scanned intraorally by intraoral scanner (IOS).

Interventions

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Implant supported hybrid prosthesis

For each patient, implant supported mandibular hybrid prosthesis will be fabricated digitally. Frameworks will be tried in patient's mouth, scanned intraorally by intraoral scanner (IOS).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. All selected patients will have four implants placed in the mandibular interforaminal region according to all -on -four concept.

2\. All selected patients have a healthy mucosa and with no clinical complications.

3\. All patients are cooperative and approve the proposed treatment protocol.

Exclusion Criteria

* 1\. Patients who reject to participate in the study. 2. Patients who need implant placement as a result of previous implant failure.
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mansoura University ,Faculty of dentistry

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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M0203023RP

Identifier Type: -

Identifier Source: org_study_id

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