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

February 22, 2024 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525EX
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The participants in this research will be drawn from the RTWP (Radboud Tooth Wear Project) patient sample which consists of nearly 200 tooth wear patients. Patients are included through dentist referral or of their own volition. Out of this population, 55 patients are managed non-restoratively, because they do not experience problems in regards to their tooth wear, and have no restorative treatment need in their perception

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Studie A ESO - monitoring
Patients that present themselves at the clinic through referral from their dentist with tooth wear, who have no request for help, receive a non-restorative 'counseling & monitoring' strategy , in which appropriate preventive measures are recommended and wear and tear is monitored and recorded by periodically taking intra-oral photographs and 3D scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of dental wear in height
Time Frame: 7 years
µm per year
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The use of index teeth
Time Frame: 7 years
ICC correlation between ranking of patients according to whole dentition or index teeth
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2011

Primary Completion (Actual)

May 21, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTWP-ESOA2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Reflux Acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe