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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Heidelberg University.
Recruitment status was  Recruiting
Information provided by:
Heidelberg University Identifier:
First received: August 3, 2011
Last updated: NA
Last verified: September 2010
History: No changes posted

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Heidelberg University:

Primary Outcome Measures:
  • Pain [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mouth opening [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Aqualizer
    The Aqualizer is a soft splint with water-filled pads.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Contact: Nikolaos N Giannakopoulos,

Department of Prosthodontics, University Clinic of Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, D-69120
Principal Investigator: Nikolaos N Giannakopoulos,         
Sponsors and Collaborators
Heidelberg University
  More Information

No publications provided

Responsible Party: Nikolaos Nikitas Giannakopoulos, Department of Prosthodontics Identifier: NCT01409850     History of Changes
Other Study ID Numbers: UHeidelberg
Study First Received: August 3, 2011
Last Updated: August 3, 2011
Health Authority: Germany: Ethics Commission processed this record on November 20, 2014