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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04586322
Other study ID # 2809ErosionC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 18, 2018
Est. completion date December 30, 2019

Study information

Verified date September 2020
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention, (observational study).
From every participant the following information was recorded for further analysis: BEWE score- Basic erosive tooth wear examination (from 2 calibrated examiners) to diagnose the presence of erosive tooth wear. Their answer to a validated questionnaire assessing the dietary habits based in the frequency of acidic diet. 2 Intra oral scans (IOS): Baseline and follow up (1 year after baseline) to perform a quantification of tissue loss (in Volume loss per mm3) using Wearcompare software.

Locations

Country Name City State
Belgium Francisca Marro Gent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Volume loss 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 Dietary Risk factors Frequency of consumption of dietary acids (Possible cut off: > 1 a day) 14 months
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