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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04790110
Collaborator
Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde (Other)
55
141

Study Details

Study Description

Brief Summary

Prospective observational study with 5-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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective observational study with 5-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.

    In a multivariate statistical model the loss of tooth material per tooth type will be tested against possible individual risk factors such as bruxism and reflux. An interim analysis will be performed to test the feasibility of the research.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    55 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Progression of Tooth Wear and Possible Risk Factors: a 5 Year Follow up
    Actual Study Start Date :
    Mar 3, 2011
    Anticipated Primary Completion Date :
    May 21, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. degree of dental wear in height [5 years]

      µm per year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Radboud University Medical Center
    • Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04790110
    Other Study ID Numbers:
    • NTWP-ESOA2020
    First Posted:
    Mar 10, 2021
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Jan 1, 2021
    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:
    No
    Keywords provided by Radboud University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 17, 2021