Effect of Geometric Modifications of Implant Scan Bodies

NCT06040385 | Completed

• 1 other identifier: M0203023RP
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (2)

• passivity of the prosthesis

  Radiographic evaluation using long cone parallel technique will be done for the framework

  one year

• 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 Outcomes (1)

• patient satisfaction

  one year

Study Arms (2)

• Group I (control group)

ACTIVE COMPARATOR

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

• Group II (Test Group)

ACTIVE COMPARATOR

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

Interventions

Implant supported hybrid prosthesis 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 I (control group); • Group II (Test Group)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All selected patients will have four implants placed in the mandibular interforaminal region according to all -on -four concept.
• \. All selected patients have a healthy mucosa and with no clinical complications.
• \. All patients are cooperative and approve the proposed treatment protocol.

You may not qualify if:

• \. Patients who reject to participate in the study. 2. Patients who need implant placement as a result of previous implant failure.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University ,Faculty of dentistry

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 15, 2023
• Study Start: March 20, 2023
• Primary Completion: May 7, 2024
• Study Completion: February 16, 2025
• Last Updated: August 14, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)