- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04586322
Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.
Association Between Erosive Tooth Wear Progression and Dietary Risk Factors in Chileans Adolescents.
Study to determine if whether or not exist an association between the tissue loss (ETW progression) and the frequency of an acidic diet. To accomplish the aim, a quantitative analysis of intraoral scans of study models will be performed to identify erosive tooth wear progression in a group of Chilean adolescents.
First, participants with different intake of dietary acids will be compared in terms of their baseline sociodemographic and clinical characteristics. Second, the association between baseline frequency of dietary acids and changes in volume loss over time will be evaluated using linear mixed models to account for the data structure (repeated assessments nested within teeth and teeth nested within children). Models will be adjusted for demographic factors, family socioeconomic position, health behaviours and chronic conditions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Gent, Belgium, 9000
- Francisca Marro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female (age range 10-18) assisting in a school with low socioeconomic status.
They must have: -Complete record of questionnaires
- Baseline and Follow-up Intra oral scanners (with correct alignment when using Wearcompare software)
- BEWE scores
- Signed Inform consent
Exclusion Criteria:
- Patients not willing to participate
- Patients wearing orthodontic appliances
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume loss
Time Frame: 14 months
|
Volume Loss in mm3 in patients having a frequent consumption of dietary acids (cut off to decide) Volume loss will be determined by aligning the marker teeth of each participant: 1.1-2.1-1.6-2.6-3.6 and 4.6.
|
14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary Risk factors
Time Frame: 14 months
|
Frequency of consumption of dietary acids (Possible cut off: > 1 a day)
|
14 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2809ErosionC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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