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CompletedNCT04586322Updated Oct 14, 2020

Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.

An observational study in Tooth Erosion, Tooth Wear and Erosion, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by University Ghent · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
71
Ages
10 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tooth Erosion
  • Tooth Wear
  • Erosion
  • Dental Erosion

Keywords

  • Tooth Erosion
  • Tooth wear
03

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adolescents subscribed at 2 Chilean high schools of the Community La Pintana, Santiago de Chile (Colegio Nocedal and Colegio Almendral). Schools belong to a low socio economic status sector.

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

Exclusion Criteria:

  • Patients not willing to participate
  • Patients wearing orthodontic appliances
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
71 participants (actual)
Patient registry
No

Interventions

  • OtherNo 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 14 months

Secondary outcomes

  1. Dietary Risk factors

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

    Time frame: 14 months

06

Study locations

1 site
  • Francisca Marro
    Gent, 9000, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04586322
Lead sponsor
University Ghent
Responsible party
Sponsor
First posted
Oct 14, 2020
Start date
Oct 18, 2018
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019
Last update
Oct 14, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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