Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05760482 - Evaluation of the Relationship Between Bruxism and Tryptophan Metabolites N/A
Enrolling by invitation NCT02235220 - Reduction of Masticatory Muscle Activity by Restoring Canine Guidance N/A
Recruiting NCT05995431 - Impact of Bruxism in the Outcome of Subgingival Instrumentation for the Management of Stage 2 and Stage 3 Periodontitis. N/A
Recruiting NCT05604729 - The Effect on Envelope of Motion in Asymptomatic Bruxers N/A
Not yet recruiting NCT05764694 - Correlation Between the Occurrence of School Bullying, Victimization, and the Occurrence of Deleterious Oral Habits.
Completed NCT06258070 - Clinical Performance of Therapeutic Use of BTX for Bruxism N/A
Completed NCT04363931 - Investigation of the Effects of Kinesio Taping and Manual Therapy in Patients With Bruxism N/A
Terminated NCT01005511 - Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism N/A
Not yet recruiting NCT06052709 - Investigation of Occupational Balance in Individuals With and Without Bruxism N/A
Recruiting NCT06037798 - The Cranio-cervical Flexion Test Using the NOD Device
Recruiting NCT03006133 - Prevalence of Bruxism in a Group of Preschool Egyptian Children N/A
Completed NCT02257320 - TMJ NextGeneration(TM) Feasibility Study N/A
Completed NCT04884152 - Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism N/A
Recruiting NCT04722809 - Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology Phase 3
Completed NCT01463826 - Respiratory Problems and Caries in Children With Bruxism N/A
Completed NCT05416788 - Effect of Cervical Manipulation on Mouth Opening N/A
Not yet recruiting NCT06386809 - Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism N/A
Recruiting NCT05562531 - Botulinum Toxin Administration on Masticatory Performance
Enrolling by invitation NCT06377475 - Fabrication and Insertion of Michigan Splints by Dental Students
Active, not recruiting NCT03713827 - Clinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism N/A