Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.
- Conditions
- Myofascial Pain
- Interventions
- Device: AqualizerDevice: Soft splint
- Registration Number
- NCT01409850
- Lead Sponsor
- Heidelberg University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
- Adult patients, non-chronic orofacial pain
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aqualizer Aqualizer - Soft splint Soft splint elastic splint made of copolyester foil
- Primary Outcome Measures
Name Time Method Pain 2-3 weeks
- Secondary Outcome Measures
Name Time Method mouth opening 2-3 weeks
Trial Locations
- Locations (1)
Department of Prosthodontics, University Clinic of Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany