Comparison of treatment outcome with a full-occlusion biofeedback splint on sleep bruxism and TMD pain compared to treatment with an adjusted occlusal splint

Not Applicable

• Conditions: F45.8; Other somatoform disorders

• Registration Number: DRKS00018092
• Lead Sponsor: Poliklinik für Zahnärztliche Prothetik LM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-04-04
• Study Start: 2020-05-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

(1) physical signs of bruxism visible on the dentition (grinding facets, abnormal tooth wear and/or wedge-shaped lesions)
(2) self-reported pain in the masticatory muscles and/or the temporomandibular joint (TMJ”)
(3) willingness of the patient to participate in the study and a commitment to adhere to the pre-set timetable.

Exclusion Criteria

(1) acute pain caused by other components of the masticatory system (e.g. caries, root inflammation)
(2) prior or planned TMJ or dysgnathia surgery
(3) jaw fractures, (4) otorhinolaryngologic diseases (except tinnitus), (5) systemic basic illness with rheumatic origin e.g. arthritis, arthrosis, gout and psoriasis, (6) psychosomatic or psychiatric diseases, (7) implanted electronic devices, (8) arrhythmia and other (prior or present) cardiac problems, (9) epilepsy, (10) cerebrovascular and brain diseases, (11) pregnancy including breastfeeding period, (12) drug or alcohol abuse, analgesic or sedative therapy, use of medication affecting the central nervous system (e.g. antidepressants, anxiolytics and anticonvulsants), (13) physical or mental disability, (14) maxillary hyperesthesia and/or allergy to materials used, (15) missing support zones in the posterior region or anatomical topography which made a full-coverage maxillary splint impossible to use, (16) a past history of received biofeedback therapy and (17) insufficient recorded bruxing activity in the baseline phase

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recording of bruxism activity 2018

Secondary Outcome Measures

Name	Time	Method
Aquisition of questionnaire and clinical examination 2018