Status:
UNKNOWN
Pressure Algometry Evaluation of Two Occlusal Splint Designs in Bruxism Management - RCT
Lead Sponsor:
Pomeranian Medical University Szczecin
Conditions:
Bruxism
Sleep Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy.. Two study groups will be formed. T...
Detailed Description
During the study, designated pressure points before and after one month of splint usage will be evaluated as possible indicators of two different splints efficacy.. Two study groups will be formed. T...
Eligibility Criteria
Inclusion
- I. Nocturnal Bruxism according to International Classification of Sleep Disorders, Second Edition (ICSD-2).
- A. The patient reports or is aware of tooth-grinding sounds or tooth clenching during sleep.
- B. One or more of the following is present: a. Abnormal wear of teeth b. Jaw muscle discomfort, fatigue, or pain and jaw lock upon awakening. c. Masseter muscle hypertrophy upon voluntary forceful clenching.
- C. The jaw muscle activity is not better explained by another current sleep disorder, medical or neurological disorder, medication use, or substance use disorder.
- II. Additional questionnaire for detecting bruxers:
- Has anyone heard you grinding your teeth at night? Is your jaw ever fatigued or sore in the morning? Are your teeth or gums ever sore on awakening in the morning? Do you ever experience temporal headaches on awakening in the morning? Are you aware of grinding your teeth during the day? Are you ever aware of clenching your teeth during the day Can you imitate a sound of grinding using your teeth.
Exclusion
- unrestored tooth losses
- patients wearing removable dentures of any kind
- psychiatric conditions undermining/preventing occlusal splint usage
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04733573
Start Date
January 1 2021
End Date
June 30 2021
Last Update
June 22 2021
Active Locations (1)
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1
Chair and Depratment of Dental Prosthetics
Szczecin, Poland