- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05843513
Tooth Wear Monitoring Using Intraoral Scanner
May 11, 2023 updated by: Díaz-Flores García, Universidad Europea de Madrid
Tooth Wear Monitoring Using Intraoral Scanner. Identification of Etiological Factors and Patient Satisfaction.
The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner.
Forty-six participants were selected according to the established inclusion and exclusion criteria.
Monitoring of tooth wear, evaluation of possible aetiological factors, as well as patient satisfaction with the use of the intraoral scanner were carried out.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner.
The specific objectives were (1) to determine whether the intraoral scanner is capable of detecting tooth wear superior to traditional visual indices, (2) to identify whether any aetiological factors may be associated with tooth tissue loss, (3) to establish a degree of patient satisfaction with the intraoral scanner as a diagnostic tool.
Forty-six participants were selected according to the established inclusion and exclusion criteria.
The protocol was accepted by the Regional Ethics Committee of the Community of Madrid.
Digitisation of the dental arches was recorded at 3 types of evaluation: 0, 6 months and 12 months.
The recording of possible etiologic factors was carried out at the three established evaluation times.
The evaluation of satisfaction was recorded at the third evaluation time.
Study Type
Observational
Enrollment (Actual)
46
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
-
-
Madrid
-
Villaviciosa De Odón, Madrid, Spain, 28670
- Universidad Europea de Madrid
-
-
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
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Adults between 18 to 40.
Description
Inclusion Criteria:
- patients over 18 years of age
- patients who were to stay at the university for more than one and a half years
- patients who agreed to sign the informed consent form.
Exclusion Criteria:
- pregnant women
- patients who planned to modify the oral situation with orthodontic, surgical and/or rehabilitative treatments
- patients who had some kind of personal or academic relationship with the investigators of this study.
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 |
Intervention / Treatment |
|---|---|
|
Monitoring
From every participant the following information was recorded for further analysis:
|
The relationship between dental wear and the behaviour of the participants will be analysed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tooth wear monitoring
Time Frame: 1 year
|
Quantification of tissue loss (more than 100 microns) using intraoral scanner related with possible etiological factors
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Garcia VD, Freire Y, Fernandez SD, Murillo BT, Sanchez MG. Application of the Intraoral Scanner in the Diagnosis of Dental Wear: An In Vivo Study of Tooth Wear Analysis. Int J Environ Res Public Health. 2022 Apr 8;19(8):4481. doi: 10.3390/ijerph19084481.
- Travassos da Rosa Moreira Bastos R, Teixeira da Silva P, Normando D. Reliability of qualitative occlusal tooth wear evaluation using an intraoral scanner: A pilot study. PLoS One. 2021 Mar 25;16(3):e0249119. doi: 10.1371/journal.pone.0249119. eCollection 2021.
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)
January 18, 2019
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
August 30, 2021
Study Registration Dates
First Submitted
April 24, 2023
First Submitted That Met QC Criteria
April 24, 2023
First Posted (Actual)
May 6, 2023
Study Record Updates
Last Update Posted (Actual)
May 15, 2023
Last Update Submitted That Met QC Criteria
May 11, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Desgaste-UE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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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