Clinical trial NCT04653519: Accuracy and Reproducibility of Virtually Guided Minimally Invasive Tooth Preparations Using Reverse Engineering
Official title: Accuracy and Reproducibility of Virtually Guided Minimally Invasive Tooth Preparations Using Reverse Engineering (Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Marginal Adaptation of Fixed Dental Prosthesis
Keywords: Minimally invasive tooth preparations
Reverse engineering
Virtually guided tooth preparation
Digital assessment of tooth preparation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the virtually guided tooth preparation accuracy
timeFrame: 1 month
measure: 3-D Evaluation of absolute marginal discrepancy using reverse engineering
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Fayoum University, Egypt
name: Yara H Attia, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Samir I Bakry, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Sanaa H Abd El Kader, PhD
role: STUDY_DIRECTOR
References: