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||Phase|
|Myofascial Pain||Device: Aqualizer Device: Soft splint||Not Applicable|
|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|
|Actual Primary Completion Date :||December 2012|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|