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Effect of Geometric Modifications of Implant Scan Bodies

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ClinicalTrials.gov Identifier: NCT06040385
Recruitment Status : Active, not recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Prosthesis Durability Device: Implant supported hybrid prosthesis Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Geometric Modifications of Implant Scan Bodies Compared to Conventional Transfer Techniques on Passivity of Mandibular All on Four Restorations
Actual Study Start Date : March 20, 2023
Estimated Primary Completion Date : December 7, 2023
Estimated Study Completion Date : December 16, 2024

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: • 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.
 Device: 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).
Active Comparator: • 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
 Device: 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).


Outcome Measures
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Primary Outcome Measures :
  1. passivity of the prosthesis [ Time Frame: one year ]
    Radiographic evaluation using long cone parallel technique will be done for the framework

  2. trueness of final impressions [ Time Frame: one year ]
    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


Secondary Outcome Measures :
  1. patient satisfaction [ Time Frame: one year ]
    patient satisfaction will be evaluated using Visual analogue scale questionnaire


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040385


Locations
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Egypt
Mansoura University ,Faculty of dentistry
Mansoura, Egypt, 35516
Sponsors and Collaborators
Mansoura University
More Information
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT06040385    
Other Study ID Numbers: M0203023RP
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prosthesis Failure
Postoperative Complications
Pathologic Processes