Myofascial Pain
Conditions
Brief summary
The most commonly applied treatment against acute temporomandibular signs and symptoms is pharmacotherapy. The evidence on treatment efficacy of non-medication treatments (like splints) is very low. Two very commonly used splints are the Aqualizer® and the soft polyester splint. These are splints applied for a short period of time, until the treatment with a hard splint and/or physiotherapy begins. Aim of this study is to compare the clinical short-time efficacy of these two splints for the treatment of acute temporomandibular pain and compare it to a control group receiving no therapy for that short time. The study hypothesis is that there is a difference in pain reduction between the three groups of patients (two intervention and one control group).
Interventions
DEVICEAqualizer
The Aqualizer is a soft splint with water-filled pads.
DEVICESoft splint
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, non-chronic orofacial pain
Exclusion criteria
* Pregnancy, chronic orofacial pain, dental treatment need, dental pain, edentulous space larger than 5mm, more than three molars missing in the same quadrant, rheumatic disease, Injury/operation in maxillofacial area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain | 2-3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| mouth opening | 2-3 weeks |
Countries
Germany
Outcome results
None listed