NCT06672627

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

October 31, 2024

Last Update Submit

November 3, 2024

Conditions

Dental OcclusionOcclusal Analysis

Keywords

Occlusal analysisOcclusenseIntraoral scanners

Outcome Measures

Primary Outcomes (1)

  • Evaluation of trueness

    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 Outcomes (1)

  • Inter-examiner reliability

    4 months

Study Arms (3)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Rania Elsayed Ramadan, PhD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Prosthodontics

Study Record Dates

First Submitted

October 31, 2024

First Posted

November 4, 2024

Study Start

September 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 30, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations

EG(1)