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Effect of Geometric Modifications of Implant Scan Bodies

Primary Purpose

Prosthesis Durability

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Implant supported hybrid prosthesis
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prosthesis Durability

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mansoura University ,Faculty of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

• Group I (control group)

• Group II (Test Group)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

patient satisfaction
patient satisfaction will be evaluated using Visual analogue scale questionnaire

Full Information

First Posted
September 4, 2023
Last Updated
September 13, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT06040385
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
December 7, 2023 (Anticipated)
Study Completion Date
December 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

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

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthesis Durability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
• Group I (control group)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
• Group II (Test Group)
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Implant supported hybrid prosthesis
Intervention Description
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).
Primary Outcome Measure Information:
Title
passivity of the prosthesis
Description
Radiographic evaluation using long cone parallel technique will be done for the framework
Time Frame
one year
Title
trueness of final impressions
Description
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
Time Frame
one year
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
patient satisfaction will be evaluated using Visual analogue scale questionnaire
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Mansoura University ,Faculty of dentistry
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Geometric Modifications of Implant Scan Bodies

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