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

This study has been terminated.
(Very slow enrollment of participants)
Information provided by (Responsible Party):
Giannakopoulos Nikolaos, Heidelberg University Identifier:
First received: August 3, 2011
Last updated: December 2, 2014
Last verified: December 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 Intervention
Myofascial Pain Device: Aqualizer Device: Soft splint

Study Type: Interventional
Study Design: 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.

Further study details as provided by Giannakopoulos Nikolaos, Heidelberg University:

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

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

Enrollment: 36
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01409850

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

Responsible Party: Giannakopoulos Nikolaos,,MSc, Heidelberg University Identifier: NCT01409850     History of Changes
Other Study ID Numbers: UHeidelberg
Study First Received: August 3, 2011
Last Updated: December 2, 2014 processed this record on September 21, 2017