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

Tracking Information

• First Submitted Date: September 4, 2023
• First Posted Date: September 15, 2023
• Last Update Posted Date: September 15, 2023
• Actual Study Start Date: March 20, 2023
• Estimated Primary Completion Date: December 7, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2023)

• passivity of the prosthesis [ Time Frame: one year ]
  Radiographic evaluation using long cone parallel technique will be done for the framework
• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 13, 2023)

patient satisfaction [ Time Frame: one year ]

patient satisfaction will be evaluated using Visual analogue scale questionnaire

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Geometric Modifications of Implant Scan Bodies
• Official Title: Effect of Geometric Modifications of Implant Scan Bodies Compared to Conventional Transfer Techniques on Passivity of Mandibular All on Four Restorations
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Prosthesis Durability

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).

Study Arms

• 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.
  Intervention: Device: Implant supported hybrid prosthesis
• 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
  Intervention: Device: Implant supported hybrid prosthesis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 13, 2023): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 16, 2024
• Estimated Primary Completion Date: December 7, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT06040385
• Other Study ID Numbers: M0203023RP
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mansoura University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mansoura University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Mansoura University
• Verification Date: September 2023