NCT06272474

Brief Summary

Computer-aided designs have considered dynamic occlusion with virtual articulator systems. However, the process involved is currently lengthy. The simplified transfer of casts from a mechanical to a virtual articulator has required bulky and expensive instruments. Recently, new methods based on mandibular motion tracking using optical devices have been introduced for integrating individual functional movement into occlusal morphology. The aim of this study: This study will clinically assess the reliability of the virtual reproduction of mandibular movement for detecting occlusal interferences and adjustments of designed and milled CAD-CAM zirconia crowns using a digital occlusal analyzer. Materials and methods: Intraoral optical impression will be made for thirteen selected patients with endodontically treated maxillary first premolars after abutment preparation followed by buccal and lateral interocclusal records taking. Two zirconia crowns will be fabricated for each patient following regular digital workflow with twenty six zirconia crowns, which will be allocated according to the virtual method of adjustment of occlusal interferences into two groups (Group I: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record (n=13) and Group II: Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal and lateral interocclusal records (n=13)). Then milling and sintering of all crowns will be performed following the manufacturer's instructions. The occlusion of all crowns will be analyzed using an electronic pressure analyzer. All data will be statistically analyzed and discussed in light of the results obtained.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

February 15, 2024

Last Update Submit

February 15, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Static occlusal interference

    it is measured at patient's maximum intercuspation using occlusense device

    Through study completion, average 12 months

  • Dynamic occlusal interference

    it is measured at patient's lateral mandibular movement using occlusense device

    Through study completion, average 12 months

Study Arms (2)

Buccal interocclusal records

ACTIVE COMPARATOR
Other: CAD-CAM zirconia crowns using buccal interocclusal record.

Lateral interocclusal records

EXPERIMENTAL
Other: CAD-CAM zirconia crowns using lateral interocclusal records.

Interventions

Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using buccal interocclusal record. First, scanning the buccal interocclusal record for each patient with the two arches in maximum intercuspation position (MIP) will be performed. The IOS will immediately reproduce the occlusal state of the digital casts; this method is called the buccal bite registration method (BBR).

Buccal interocclusal records

Virtual occlusal interferences adjustment of CAD-CAM zirconia crowns using lateral interocclusal record. A second scan will be performed for each patient to record lateral mandibular excursion. Then, three STL files will be exported; maxillary arch, mandibular arch at MIP and lateral mandibular excursion

Lateral interocclusal records

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patient presented with successful endodontically treated maxillary 1st premolar.
  • Patients having class I occlusion.
  • Good oral hygiene with no signs of periapical pathology or periodontal disease(24).
  • Patient having natural teeth as opposed to dentition.

You may not qualify if:

  • Pregnancy, which prevents the use of diagnostic x-rays.
  • Parafunctional habits.
  • Mobility in the abutment teeth more than grade 1.
  • Patient presenting allergy to materials being used.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Single group is receiving the two interventional arms
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start

September 11, 2022

Primary Completion

December 9, 2023

Study Completion

December 9, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations