Tooth ErosionNCT04586322
Association Between Erosive Tooth Wear Progression and Dietary Risk Factors.
An observational study of Tooth Erosion and Tooth Wear, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Erosion, Tooth Wear, Erosion
- Type of treatment
- Pill or oral medicine
- How many people
- 71 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Oct 2018to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- Patients not willing to participate
- Patients wearing orthodontic appliances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tooth Erosion, Tooth Wear, Erosion, Dental Erosion
- Being tested
- No intervention, (observational study).
- Keywords
- Tooth Erosion, Tooth wear
- Medical subject headings
- Tooth Erosion, Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 months
Secondary outcomes (1)
Dietary Risk factors
Frequency of consumption of dietary acids (Possible cut off: > 1 a day)
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start18 Oct 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ErosionStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586322
- Sponsor's protocol ID
- 2809ErosionC
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Erosive Tooth Wear Progression and Dietary Risk Factors in Chileans Adolescents.
- ClinicalTrials.gov ID
- NCT04586322
- Acronym / sponsor ID
- 2809ErosionC
- Conditions
- Tooth Erosion, Tooth Wear, Erosion, Dental Erosion
- Keywords
- Tooth Erosion, Tooth wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Patients not willing to participate
- Patients wearing orthodontic appliances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | – |
Primary outcome
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.
1 secondary outcome
Dietary Risk factors
Time frame: 14 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Erosion and Tooth Wear, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume loss (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.