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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04790110
Other study ID # NTWP-ESOA2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2011
Est. completion date June 1, 2022

Study information

Verified date October 2022
Source Radboud University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date June 1, 2022
Est. primary completion date May 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Radboud University Medical Center Nijmegen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Radboud University Medical Center Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Ahmed KE, Whitters J, Ju X, Pierce SG, MacLeod CN, Murray CA. Clinical Monitoring of Tooth Wear Progression in Patients over a Period of One Year Using CAD/CAM. Int J Prosthodont. 2017 Mar/Apr;30(2):153-155. doi: 10.11607/ijp.4990. — View Citation

Loomans B, Opdam N, Attin T, Bartlett D, Edelhoff D, Frankenberger R, Benic G, Ramseyer S, Wetselaar P, Sterenborg B, Hickel R, Pallesen U, Mehta S, Banerji S, Lussi A, Wilson N. Severe Tooth Wear: European Consensus Statement on Management Guidelines. J Adhes Dent. 2017;19(2):111-119. doi: 10.3290/j.jad.a38102. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary degree of dental wear in height µm per year 7 years
Secondary The use of index teeth ICC correlation between ranking of patients according to whole dentition or index teeth 7 years
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