Tooth Wear Monitoring Using Intraoral Scanner

Sponsor
Universidad Europea de Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT05843513
Collaborator
(none)
46
1
31.4
1.5

Study Details

Study Description

Brief 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. Monitoring of tooth wear, evaluation of possible aetiological factors, as well as patient satisfaction with the use of the intraoral scanner were carried out.

Condition or Disease Intervention/Treatment Phase
  • Other: Monitoring (observational study)

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

Study Type:
Observational
Actual Enrollment :
46 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Tooth Wear Monitoring Using Intraoral Scanner. Identification of Etiological Factors and Patient Satisfaction.
Actual Study Start Date :
Jan 18, 2019
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Aug 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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: Endogenous abrasion: presence or absence of wear facets; carrier of occlusal splint; presence of harmful oral habits; day and/or night grinding. Exogenous abrasion: whether they bite hard or soft things. Exogenous erosion: - Environmental factors: frequent swimming. - Ingestion of acidic drinks or substances: fizzy drinks, juices, alcohol, dressings, etc. 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.

Other: Monitoring (observational study)
The relationship between dental wear and the behaviour of the participants will be analysed.

Outcome Measures

Primary Outcome Measures

  1. Tooth wear monitoring [1 year]

    Quantification of tissue loss (more than 100 microns) using intraoral scanner related with possible etiological factors

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad Europea de Madrid Villaviciosa De Odón Madrid Spain 28670

Sponsors and Collaborators

  • Universidad Europea de Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Díaz-Flores García, DDS. PhD, Universidad Europea de Madrid
ClinicalTrials.gov Identifier:
NCT05843513
Other Study ID Numbers:
  • Desgaste-UE
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Díaz-Flores García, DDS. PhD, Universidad Europea de Madrid
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023