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Study to compare the effects between the RelaxBogen and its Myo fascial approach with the occlusial splint in TMD and Bruxism therapie

Study to compare the effects between the RelaxBogen and its Myo fascial approach with the occlusial splint in TMD and Bruxism therapie - RB2

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00008848
Enrollment
34
Registered
2016-09-16
Start date
2015-07-30
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorder (TMD)/Bruxism K07.6

Interventions

Group 1: The treatment group is wearing an occlusal splint for at least three month. Through selection at random this group is treated complementary with the RelaxBogen against bruxism and symptoms of

Sponsors

Zahnarztpraxis
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: N=34 with bruxism and TMD symptomes measured with a "Bruxchecker Film" and a TMD investigation by the dentist and with scientific questionaire. Each patient needs to have, scince minimum of 3 months, an occlusal splint. An other selection criteria is, that the reason for the TMD and Bruxism is restricted to jaw, neck and shoulder pain. The patients needs to be full aged and need to have no pschological disease. People which suffue from an alcohol- oder drug disease are eccluded too

Exclusion criteria

Exclusion criteria: Exclusion criteria are: The patient is underaged or not able to give one's consent. Used a RelaxBogen before. Is depressive, a drug abuser or takes medicine that could introduce Bruxism. A trauma in the head area or the cervical spine. Planned dental restoration during the period of the study. The main pain perception analysed in the SLNR-questionaire is not located in the area of the head, shoulders or the neck.

Design outcomes

Primary

MeasureTime frame
Medical exit examination after 10 to 12 weeks of treatment with pain anamnesis, SL-NRS-questionnaire according to Stelzenmueller, dental examination, manual functional analysis, review of the application journal and analysis of the EMG-measurement. Additionally the used RelaxBogen from the intervention group are checked regarding the fitting.

Secondary

MeasureTime frame
no secondary outcome is planned

Countries

Germany

Contacts

Public ContactJochen Lambers

Zahnarztpraxis

info@zahnarztpraxis-lambers.de0 51 56 - 3 73

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026