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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409850
First Posted: August 4, 2011
Last Update Posted: December 3, 2014
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.
Information provided by (Responsible Party):
Giannakopoulos Nikolaos, Heidelberg University
  Purpose

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01409850


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

Responsible Party: Giannakopoulos Nikolaos, Dr.med.dent.,MSc, Heidelberg University
ClinicalTrials.gov Identifier: NCT01409850     History of Changes
Other Study ID Numbers: UHeidelberg
First Submitted: August 3, 2011
First Posted: August 4, 2011
Last Update Posted: December 3, 2014
Last Verified: December 2014