Bruxism Clinical Trial
Official title:
The Progression of Tooth Wear and Possible Risk Factors: a 7 Year Follow up
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 |
Verified date | October 2022 |
Source | Radboud University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University Medical Center | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Stichting Bevordering Tandheelkundige Kennis of the Nederlands Tijdschrift voor Tandheelkunde |
Netherlands,
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
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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