Effect of Geometric Modifications of Implant Scan Bodies

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

Egypt

Mansoura University ,Faculty of dentistry

Mansoura, Egypt, 35516

Sponsors and Collaborators

Mansoura University

More Information

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT06040385
• Other Study ID Numbers: M0203023RP
• First Posted: September 15, 2023
• Last Update Posted: September 15, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Prosthesis Failure; Postoperative Complications; Pathologic Processes