Dental OcclusionNCT06672627
Trueness of Digital Occlusal Analysis
An observational study of Dental Occlusion and Occlusal Analysis, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Occlusion, Occlusal Analysis
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Normal occlusion (Angle Class 1)
- No missing teeth
- No tempromandibular disorders
Who cannot join
- Patients having:
- Dental prostheses
- Extensive restorations
- Severe malocclusion
- Periodontal disease
- Excessive tooth wear
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- Orofacial pain
- Temporomandibular joint disorders
- Anterior or posterior open bite
- Active orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Occlusion, Occlusal Analysis
- Keywords
- Occlusal analysis, Occlusense, Intraoral scanners
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 months
Secondary outcomes (1)
Inter-examiner reliability
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Sep 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental OcclusionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Elsayed, Alexandria University
- Investigators
- Rania Elsayed Ramadan, PhD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672627
- Sponsor's protocol ID
- 0974-09
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trueness of Digital Occlusal Analysis Using Handheld Device Versus Intraoral Scanner (A Diagnostic Evaluative Clinical Study)
- ClinicalTrials.gov ID
- NCT06672627
- Acronym / sponsor ID
- 0974-09
- Conditions
- Dental Occlusion, Occlusal Analysis
- Keywords
- Occlusal analysis, Occlusense, Intraoral scanners
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Normal occlusion (Angle Class 1)
- No missing teeth
- No tempromandibular disorders
Key exclusion criteria (10 listed)
- Dental prostheses
- Extensive restorations
- Severe malocclusion
- Periodontal disease
- Excessive tooth wear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Inter-examiner reliability
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rania Elsayed Ramadan, PhD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Occlusion and Occlusal Analysis, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of trueness (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.