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OpenTrials
Completed

NCT Number: NCT04790110

7 Year Follow up Analysis on the Speed of Progression of Tooth Wear Using 3D Subtraction

Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and 1, 3 5, and the 7-year recall digital 3D scans will be made, which will be compared and subtracted.

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Key information

Conditions

Tooth Wear Behavior Bruxism Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Habits Reflux Acid Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboud University Medical Center

Nijmegen, Gelderland, 6525EX, Netherlands

About this study

Prospective observational study with 7-year follow up. 55 patients are included with moderate to severe tooth wear, whereby through informed consent the decision was taking to monitor the patients. At the baseline and the 5-year recall digital 3D scans will be made, which will be compared and subtracted. Per tooth the loss of material is measured in maximum loss in height (µm) and volume (mm3) per year, using best fit alignment and 3D subtraction.

The loss of tooth material will be analyzed using descriptive statistics and possible effects of jaw type, tooth type and cusp type will be analyzed using multi level regression models.

The use of index teeth will be analyzed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generalized tooth wear
  • A minimum of three posterior teeth (premolars and molars) per quadrant
  • A maximum of one edentulous space in need for treatment, with a maximum span of one tooth-width

Exclusion criteria

  • ASA 4
  • Edentulous space has a span exceeding 1 tooth-width, or more than one space
  • Functional problems (mouth opening <5cm, Temporomandibular Dysfunction)
  • Severe periodontitis
  • Strong gag reflex

Treatment and study plan

Primary outcomes

  1. degree of dental wear in height

    Time frame: 7 years

    µm per year

Secondary outcomes

  1. The use of index teeth

    Time frame: 7 years

    ICC correlation between ranking of patients according to whole dentition or index teeth

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde

Registry information

Official study title

The Progression of Tooth Wear and Possible Risk Factors: a 7 Year Follow up

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2021
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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