Trueness of Digital Occlusal Analysis

November 3, 2024 updated by: Rania Elsayed, Alexandria University

Trueness of Digital Occlusal Analysis Using Handheld Device Versus Intraoral Scanner (A Diagnostic Evaluative Clinical Study)

The aims of this observational study are to evaluate the trueness of two different digital occlusal analyzers; handheld occlusal analyzer versus intraoral scanner in comparison to conventional methods in identifying true occlusal contacts and to evaluate inter-examiner reliability of two examiners independently analyzing occlusal contacts.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Evaluate the trueness of two different digital occlusal analyzers; handheld occlusal analyzer (occlusense) versus intraoral scanner (Medit i700-medit occlusal analyzer) in comparison to conventional methods (8 um articulating paper) in identifying true occlusal contacts and to evaluate inter-examiner reliability of two examiners independently analyzing occlusal contacts.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Faculty of Dentistry, Alexandria University, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

  • Normal occlusion (Angle Class 1)
  • No missing teeth
  • No tempromandibular disorders

Exclusion Criteria:

Patients having:

  • Dental prostheses
  • Extensive restorations
  • Severe malocclusion
  • Periodontal disease
  • Excessive tooth wear
  • Orofacial pain
  • Temporomandibular joint disorders
  • Anterior or posterior open bite
  • Active orthodontic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control group
Every participant will undergo occlusal analysis using conventional methods (8um articulating paper)
Study group I
Every participant will undergo digital occlusal analysis using hand held device (occlusense)
Study group II
Every participant will undergo digital occlusal analysis using intraoral scanner (Medit occlusal analyzer)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of trueness
Time Frame: 4 months
Trueness is defined as the closeness of the measurement to the real size of an object. The trueness of handheld occlusal analyzers (occlusense) versus intraoral scanners (medit occlusal analyzer) will be evaluated in comparison to conventional methods (8 um articulating paper).
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-examiner reliability
Time Frame: 4 months
Two examiners will record independently the interocclusal contacts for all the different groups, classifying them in a dichotomy variable (yes/no) contact or not per tooth. Then, the inter-examiner's reliability will be calculated.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Rania Elsayed Ramadan, PhD, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

November 1, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 3, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0974-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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