Effect of Geometric Modifications of Implant Scan Bodies

Not Applicable

Active, not recruiting

• Conditions: Prosthesis Durability
• Interventions: Device: Implant supported hybrid prosthesis

• Registration Number: NCT06040385
• Lead Sponsor: Mansoura University

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

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 Timeline

• Study Start: 2023-03-20
• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-15
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-05-07
• Study Completion: 2024-12-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
• Group II (Test Group)	Implant supported hybrid prosthesis	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 I (control group)	Implant supported hybrid prosthesis	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.

Primary Outcome Measures

Name	Time	Method
passivity of the prosthesis	one year	Radiographic evaluation using long cone parallel technique will be done for the framework
trueness of final impressions	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

Name	Time	Method
patient satisfaction	one year	patient satisfaction will be evaluated using Visual analogue scale questionnaire

Trial Locations

Locations (1)

Mansoura University ,Faculty of dentistry; 🇪🇬 Mansoura, Egypt