Dental WearNCT05843513
Tooth Wear Monitoring Using Intraoral Scanner
An observational study of Dental Wear, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. Forty-six participants were selected according to the established inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dental Wear
- What is being tested?
- Monitoring (observational study)
- Type of treatment
- Pill or oral medicine
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jan 2019to 30 Aug 2021
- 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 18 to 40 years
- All sexes
- Adult
Study population: Adults between 18 to 40.
Who may be able to join
- patients over 18 years of age
- patients who were to stay at the university for more than one and a half years
- patients who agreed to sign the informed consent form.
Who cannot join
- pregnant women
- patients who planned to modify the oral situation with orthodontic, surgical and/or rehabilitative treatments
- patients who had some kind of personal or academic relationship with the investigators of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tooth Wear Monitoring Using Intraoral Scanner. Identification of Etiological Factors and Patient Satisfaction.
The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. Forty-six participants were selected according to the established inclusion and exclusion criteria. Monitoring of tooth wear, evaluation of possible aetiological factors, as well as patient satisfaction with the use of the intraoral scanner were carried out.
Read the detailed description
The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. The specific objectives were (1) to determine whether the intraoral scanner is capable of detecting tooth wear superior to traditional visual indices, (2) to identify whether any aetiological factors may be associated with tooth tissue loss, (3) to establish a degree of patient satisfaction with the intraoral scanner as a diagnostic tool. Forty-six participants were selected according to the established inclusion and exclusion criteria. The protocol was accepted by the Regional Ethics Committee of the Community of Madrid. Digitisation of the dental arches was recorded at 3 types of evaluation: 0, 6 months and 12 months. The recording of possible etiologic factors was carried out at the three established evaluation times. The evaluation of satisfaction was recorded at the third evaluation time.
- Conditions
- Dental Wear
- Being tested
- Monitoring (observational study)
- Keywords
- Dental wear, Intraoral scanner, Etiological factors, Monitoring
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring (observational study)Other
The relationship between dental wear and the behaviour of the participants will be analysed.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring | From every participant the following information was recorded for further analysis:
* State Trait Anxiety Inventory (STAI) questionnaire.
* A questionnaire is carried out to assess:
1. Endogenous abrasion: presence or absence of wear facets; carrier of occlusal splint; presence of harmful oral habits; day and/or night grinding.
2. Exogenous abrasion: whether they bite hard or soft things.
3. Exogenous erosion: - Environmental factors: frequent swimming. - Ingestion of acidic drinks or substances: fizzy drinks, juices, alcohol, dressings, etc.
4. Endogenous erosion: reflux, vomiting, heartburn, nighttime drooling, etc.
* An examination of the temporomandibular joint (TMJ) is carried out; palpation of the muscles most frequently related to bruxism and/or alterations of the TMJ.
* 2 Intra oral scans (IOS): Baseline and follow up (1 year after baseline) to perform a quantification of tissue loss (over 100 microns) using Geomagic software. Receives: Other: Monitoring (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth wear monitoring
Quantification of tissue loss (more than 100 microns) using intraoral scanner related with possible etiological factors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start18 Jan 2019
- Primary completion1 Jan 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental WearStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Díaz-Flores García, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843513
- Sponsor's protocol ID
- Desgaste-UE
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Garcia VD, Freire Y, Fernandez SD, Murillo BT, Sanchez MG. Application of the Intraoral Scanner in the Diagnosis of Dental Wear: An In Vivo Study of Tooth Wear Analysis. Int J Environ Res Public Health. 2022 Apr 8;19(8):4481. doi: 10.3390/ijerph19084481.
PubMed 35457351Travassos da Rosa Moreira Bastos R, Teixeira da Silva P, Normando D. Reliability of qualitative occlusal tooth wear evaluation using an intraoral scanner: A pilot study. PLoS One. 2021 Mar 25;16(3):e0249119. doi: 10.1371/journal.pone.0249119. eCollection 2021.
PubMed 33765042
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tooth Wear Monitoring Using Intraoral Scanner. Identification of Etiological Factors and Patient Satisfaction.
- ClinicalTrials.gov ID
- NCT05843513
- Acronym / sponsor ID
- Desgaste-UE
- Conditions
- Dental Wear
- Keywords
- Dental wear, Intraoral scanner, Etiological factors, Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 6 May 2023 (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.
The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. Forty-six participants were selected according to the established inclusion and exclusion criteria. Monitoring of tooth wear, evaluation of possible aetiological factors, as well as patient satisfaction with the use of the intraoral scanner were carried out.
Detailed description
The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. The specific objectives were (1) to determine whether the intraoral scanner is capable of detecting tooth wear superior to traditional visual indices, (2) to identify whether any aetiological factors may be associated with tooth tissue loss, (3) to establish a degree of patient satisfaction with the intraoral scanner as a diagnostic tool. Forty-six participants were selected according to the established inclusion and exclusion criteria. The protocol was accepted by the Regional Ethics Committee of the Community of Madrid. Digitisation of the dental arches was recorded at 3 types of evaluation: 0, 6 months and 12 months. The recording of possible etiologic factors was carried out at the three established evaluation times. The evaluation of satisfaction was recorded at the third evaluation time.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring | – | Other: Monitoring (observational study)From every participant the following information was recorded for further analysis: * State Trait Anxiety Inventory (STAI) questionnaire. * A questionnaire is carried out to assess: 1. Endogenous abrasion: presence or absence of wear facets; carrier of occlusal splint; presence of harmful oral habits; day and/or night grinding. 2. Exogenous abrasion: whether they bite hard or soft things. 3. Exogenous erosion: - Environmental factors: frequent swimming. - Ingestion of acidic drinks or substances: fizzy drinks, juices, alcohol, dressings, etc. 4. Endogenous erosion: reflux, vomiting, heartburn, nighttime drooling, etc. * An examination of the temporomandibular joint (TMJ) is carried out; palpation of the muscles most frequently related to bruxism and/or alterations of the TMJ. * 2 Intra oral scans (IOS): Baseline and follow up (1 year after baseline) to perform a quantification of tissue loss (over 100 microns) using Geomagic software. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- Adults between 18 to 40.
Key inclusion criteria (3 listed)
- patients over 18 years of age
- patients who were to stay at the university for more than one and a half years
- patients who agreed to sign the informed consent form.
Key exclusion criteria (3 listed)
- pregnant women
- patients who planned to modify the oral situation with orthodontic, surgical and/or rehabilitative treatments
- patients who had some kind of personal or academic relationship with the investigators of this study.
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 |
|---|---|---|
| Monitoring (observational study)The relationship between dental wear and the behaviour of the participants will be analysed. | Other | Monitoring |
Primary outcome
Tooth wear monitoring
Time frame: 1 year
Quantification of tissue loss (more than 100 microns) using intraoral scanner related with possible etiological factors
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 15 May 2023.
- Results publication: PubMed 35457351Garcia VD, Freire Y, Fernandez SD, Murillo BT, Sanchez MG. Application of the Intraoral Scanner in the Diagnosis of Dental Wear: An In Vivo Study of Tooth Wear Analysis. Int J Environ Res Public Health. 2022 Apr 8;19(8):4481. doi: 10.3390/ijerph19084481.
- Results publication: PubMed 33765042Travassos da Rosa Moreira Bastos R, Teixeira da Silva P, Normando D. Reliability of qualitative occlusal tooth wear evaluation using an intraoral scanner: A pilot study. PLoS One. 2021 Mar 25;16(3):e0249119. doi: 10.1371/journal.pone.0249119. eCollection 2021.
- 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 Dental Wear, run by Universidad Europea de Madrid at 1 site in Spain.
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 3 inclusion and 3 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 15 May 2023. 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 Spain. 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?
Tooth wear monitoring (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843513, which also lists 2 linked publications.
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 15 May 2023.