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

Bruxism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790110
• Other study ID #: NTWP-ESOA2020
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bruxism
• Disease Progression
• Reflux Acid
• Tooth Wear

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