Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409850
Recruitment Status : Terminated (Very slow enrollment of participants)
First Posted : August 4, 2011
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
Giannakopoulos Nikolaos, 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).

Condition or disease Intervention/treatment Phase
Myofascial Pain Device: Aqualizer Device: Soft splint Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Aqualizer Device: 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

Primary Outcome Measures :
  1. Pain [ Time Frame: 2-3 weeks ]

Secondary Outcome Measures :
  1. mouth opening [ Time Frame: 2-3 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01409850

Department of Prosthodontics, University Clinic of Heidelberg
Heidelberg, Baden-Württemberg, Germany, D-69120
Sponsors and Collaborators
Heidelberg University

Responsible Party: Giannakopoulos Nikolaos,,MSc, Heidelberg University Identifier: NCT01409850     History of Changes
Other Study ID Numbers: UHeidelberg
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014