Effect of Geometric Modifications of Implant Scan Bodies

Prosthesis Durability Clinical Trial

Official title:

Effect of Geometric Modifications of Implant Scan Bodies Compared to Conventional Transfer Techniques on Passivity of Mandibular All on Four Restorations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06040385
• Other study ID #: M0203023RP
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: December 16, 2024

Study information

• Verified date: September 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 16, 2024
• Est. primary completion date: May 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis Durability
• Prosthesis Failure

Intervention

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).

Locations

Country	Name	City	State
Egypt	Mansoura University ,Faculty of dentistry	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	passivity of the prosthesis	Radiographic evaluation using long cone parallel technique will be done for the framework	one year
Primary	trueness of final impressions	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	one year
Secondary	patient satisfaction	patient satisfaction will be evaluated using Visual analogue scale questionnaire	one year