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Completed

NCT Number: NCT04586322

Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Francisca Marro

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention, (observational study).

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dietary Risk factors

    Time frame: 14 months

    Frequency of consumption of dietary acids (Possible cut off: > 1 a day)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Association Between Erosive Tooth Wear Progression and Dietary Risk Factors in Chileans Adolescents.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2020
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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