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Accuracy and Reproducibility of Virtually Guided Minimally Invasive Tooth Preparations Using Reverse Engineering

NCT ID: NCT04653519

Last Updated: 2020-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2022-01-31

Brief Summary

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The aim of the study is to assess and reproduce standardized virtually guided minimally invasive tooth preparations using digitally designed occlusal template, compared to its reference virtual preparation using a computer aided 3-dimensional (3-D) analysis, and to investigate the effect of these preparations on absolute marginal discrepancy of 3 unit monolithic translucent zirconia FPD using a computer aided 3-D analysis.

Detailed Description

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Ten patients with missing mandibular first molar will receive a three-unit full contour monolithic zirconia FPD. Each patient case will receive two modes of preparation as in the previous in-vitro study: virtually guided tooth preparation using occlusal resin template to assist the intraoral preparation and the reference virtual tooth preparation. Each participant's preparation will be evaluated using diagnostic dental software and will be compared to a reference digital virtual preparation using 3-D mesh processing reverse engineering metrology software.

Conditions

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Marginal Adaptation of Fixed Dental Prosthesis

Keywords

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Minimally invasive tooth preparations Reverse engineering Virtually guided tooth preparation Digital assessment of tooth preparation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtually guided minimally invasive preparation

Group Type EXPERIMENTAL

Virtually guided minimally invasive preparation

Intervention Type DEVICE

Intraoral virtually guided minimally invasive design with an occlusal reduction of 1.5mm, axial reduction will be performed with 6 degrees axial taper and a circumferential chamfer margin of 0.5mm in width and 0.5mm coronal to the gingival margin. A milled guiding occlusal resin template of the teeth will be checked for fitting then fixed using spot etching and will be used to guide the amount of axial reductions and taper degree.

Interventions

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Virtually guided minimally invasive preparation

Intraoral virtually guided minimally invasive design with an occlusal reduction of 1.5mm, axial reduction will be performed with 6 degrees axial taper and a circumferential chamfer margin of 0.5mm in width and 0.5mm coronal to the gingival margin. A milled guiding occlusal resin template of the teeth will be checked for fitting then fixed using spot etching and will be used to guide the amount of axial reductions and taper degree.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with a missing lower first mandibular molar.
* Good oral hygiene with no signs of periapical pathology or periodontal disease (periodontal screening index 0-1) and with compliance to perform strict oral hygiene measures.
* Well-aligned abutment teeth with similar mesio-distal (M-D) and bucco-lingual (B- L) dimensions; (2nd premolar: M-D 7.8 mm ±1, B-L 8.7 mm ±1), (2nd molar: M-D 10.73±1, B-L 10.5 mm ±1).
* Abutment teeth with an adequate occluso-gingival height where (2nd premolar: 8.4 mm ±1, 2nd molar 7mm ±1), and adequate edentulous span length (9.5 mm±1); for an appropriate connector area of at least 9 mm.
* Absence of parafunctional habits (clinching, bruxism).

Exclusion Criteria

* Bad oral hygiene.
* Advanced periodontitis, gingivitis, or recession.
* Abutments with subgingival restorations, root caries.
* Parafunctional habits.
* Undergoing orthodontic treatment.
* Obvious dentition malalignment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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yara attia

Assistant Lecturer of Fixed Prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yara H Attia, M.Sc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Fayoum University, Egypt

Samir I Bakry, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Sanaa H Abd El Kader, PhD

Role: STUDY_DIRECTOR

Faculty of Dentistry, Alexandria University, Egypt

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yara H Attia, M.Sc

Role: CONTACT

Phone: 01002539089

Email: [email protected]

Facility Contacts

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Yara H Attia, M.Sc

Role: primary

Other Identifiers

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0155-09/2020

Identifier Type: -

Identifier Source: org_study_id