Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pilot Clinical Trial on the Treatment Effectiveness of Two Splints for Acute Temporomandibular Pain.|
- Pain [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
- mouth opening [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Aqualizer||
The Aqualizer is a soft splint with water-filled pads.
Active Comparator: Soft splint
elastic splint made of copolyester foil
|Device: Soft splint|
|No Intervention: Counselling|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409850
|Department of Prosthodontics, University Clinic of Heidelberg|
|Heidelberg, Baden-Württemberg, Germany, D-69120|