Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.
|ClinicalTrials.gov Identifier: NCT01409850|
Recruitment Status : Terminated (Very slow enrollment of participants)
First Posted : August 4, 2011
Last Update Posted : December 3, 2014
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).
|Condition or disease||Intervention/treatment|
|Myofascial Pain||Device: Aqualizer Device: Soft splint|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Pilot Clinical Trial on the Treatment Effectiveness of Two Splints for Acute Temporomandibular Pain.|
|Study Start Date :||July 2010|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
|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|
- Pain [ Time Frame: 2-3 weeks ]
- mouth opening [ Time Frame: 2-3 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409850
|Department of Prosthodontics, University Clinic of Heidelberg|
|Heidelberg, Baden-Württemberg, Germany, D-69120|