F45.8
Conditions
Interventions
Group 1: Intervention group
In the intervention group, the existing dental occlusal splint therapy is continued unchanged and supplemented by three individualized osteopathic treatments within a perio
Sponsors
Dresden International University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Dentist's suspected diagnosis of primary bruxism for at least 6 months Dentist-prescribed occlusal splint
Exclusion criteria
Exclusion criteria: Acute systemic infection or acute inflammatory disease with fever Acute dental problems Pregnancy Acute or unstable psychiatric illness Botulinum toxin injections into the masticatory muscles within the last twelve months Past or planned craniofacial surgery during the study period Skull or facial skull fractures within the last twelve months Ongoing dental or orthodontic treatment Bruxism-related treatments such as OMT, manual therapy or physiotherapy within the last four weeks Planned changes in medication during the study Active cancer or other neoplasms, as well as ongoing chemotherapy or radiotherapy Active alcohol or drug addiction or abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the feasibility of the study protocol. This is determined between the baseline measurement t1 and the follow-up measurement t2 after four weeks based on adherence to osteopathic intervention, adherence to occlusal splint therapy, acceptance rate of osteopathic intervention, retention rate, and side effect rate. Adherence to osteopathic intervention is calculated from the ratio of perceived to planned osteopathic treatments. Adherence to occlusal splint therapy is assessed at t2 using two self-report items on the frequency of use and duration of wear of the occlusal splint. The acceptance rate is calculated as the ratio of subjects who have received at least one osteopathic treatment to the total number of subjects in the intervention group. The retention rate is calculated as the ratio of randomized subjects who participated in the study until the follow-up measurement to the total number of randomized subjects. Side effects are recorded verbally and documented in the intervention group after each treatment, at the start of the following treatment, and at t2, and in the control group at t2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are functional limitations of the masticatory system, perceived stress, sleep quality, and the pressure pain threshold in the jaw area. These are measured at t1 and t2 in both groups. Functional limitations of the masticatory system are measured using the Jaw Functional Limitation Scale 20 Items (JFLS-20). Perceived stress is measured using the Perceived Stress Scale 10 Items (PSS-10). Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI). The pressure pain threshold is measured using a digital algometer at three points on each side, for a total of six measurement points in the area of the temporalis muscle, the masseter muscle, and the temporomandibular joint. As an additional secondary endpoint, after completion of data collection, the required sample size for a future randomized controlled trial is calculated based on the JFLS-20 data using power analysis in G*Power. | — |
Countries
Germany
Contacts
Public ContactMareike Johanna Burmester
Dresden International University
Outcome results
None listed