NCT04586322

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
Last Updated

October 14, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

September 28, 2020

Last Update Submit

October 13, 2020

Conditions

Keywords

Tooth ErosionTooth wear

Outcome Measures

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.

    14 months

Secondary Outcomes (1)

  • Dietary Risk factors

    14 months

Interventions

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.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients not willing to participate
  • Patients wearing orthodontic appliances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francisca Marro

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Tooth ErosionTooth Wear

Interventions

Observation

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 14, 2020

Study Start

October 18, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

October 14, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations