Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447389
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-02
Brief Title:
Clinical Evaluation of Retraction Cord Effectiveness Using Intraoral Scanner
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
Clinical Evaluation of Retraction Cord Effectiveness Using Direct Digitalization Method in Determining the Preparation Margin Line
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dental-supported fixed partial dentures FPDs have long been a commonly preferred treatment method for the rehabilitation of teeth with excessive substance loss and for addressing existing tooth deficiencies Crucial factor affecting the success and quality of FPDs is the marginal fit of the restoration Marginal discrepancy refers to the vertical or horizontal gap between the restoration finish line and the preparation finish line To achieve high marginal fit restorations gingival retraction techniques are used with the aim of removing the marginal gingiva away from the finish line Retraction cords are commonly used for this purpose nowadays The aim of the study is to evaluate the effect of retraction cords on the preparation finish line and the marginal fit of produced restorations using direct digital measurement methods
Detailed Description:
This study is designed to produce temporary bridges based on two supporting teeth fabricated using an intraoral scanner and to evaluate the marginal fit of these bridges based on two different digital measurements obtained with and without the use of retraction cord on the patient
The study will encompass patients with a single missing tooth in the posterior region of the lower or upper jaw specifically involving the second premolar or first molar planned for a three-unit tooth-supported fixed partial denture SPP Prior to preparation patients will be examined for the assessment of the soft tissue around the teeth and data collection will be conducted in accordance with the criteria outlined in Table-1 following the guidelines of the 2017 Consensus Report on the Classification of Periodontal and Peri-implant Diseases and Conditions regarding periodontal health and gingival diseases in healthy and reduced periodontium
Subsequently the abutment teeth will be prepared stepwise using high-speed rotary instruments and diamond preparation burs to accommodate fixed restorations
The study groups will be formed considering the presence or absence of retraction application The groups will be defined as Group I No retraction cord and Group II Retraction cord present
In Group I digital impressions will be taken directly in all patients without placing a retraction cord
In Group II digital impressions will be taken in the same patients using a 000 knitted retraction cord and a single retraction cord technique
As part of this plan digital impressions of the abutment teeth for the temporary bridge will be taken both before and after the application of the retraction cord The temporary bridges fabricated from these impressions will then be evaluated intraorally
For each case included in the study the stl files from the initial impression for the restoration the post-production impression and the restoration itself will be superimposed and digitally analyzed using reverse engineering software
The depths of the preparation finish lines will be recorded using a probe The recorded depths of the preparation finish lines and the amounts of marginal discrepancy of the restorations will be examined together Based on the obtained data the effect of the preparation finish line depth on the marginal fit of the restorations will be evaluated
The study will encompass patients with a single missing tooth in the posterior region of the lower or upper jaw specifically involving the second premolar or first molar planned for a three-unit tooth-supported fixed partial denture SPP Prior to preparation patients will be examined for the assessment of the soft tissue around the teeth and data collection will be conducted in accordance with the criteria outlined in Table-1 following the guidelines of the 2017 Consensus Report on the Classification of Periodontal and Peri-implant Diseases and Conditions regarding periodontal health and gingival diseases in healthy and reduced periodontium
Subsequently the abutment teeth will be prepared stepwise using high-speed rotary instruments and diamond preparation burs to accommodate fixed restorations
The study groups will be formed considering the presence or absence of retraction application The groups will be defined as Group I No retraction cord and Group II Retraction cord present
In Group I digital impressions will be taken directly in all patients without placing a retraction cord
In Group II digital impressions will be taken in the same patients using a 000 knitted retraction cord and a single retraction cord technique
As part of this plan digital impressions of the abutment teeth for the temporary bridge will be taken both before and after the application of the retraction cord The temporary bridges fabricated from these impressions will then be evaluated intraorally
For each case included in the study the stl files from the initial impression for the restoration the post-production impression and the restoration itself will be superimposed and digitally analyzed using reverse engineering software
The depths of the preparation finish lines will be recorded using a probe The recorded depths of the preparation finish lines and the amounts of marginal discrepancy of the restorations will be examined together Based on the obtained data the effect of the preparation finish line depth on the marginal fit of the restorations will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None