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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:
Information provided by (Responsible Party):
Giannakopoulos Nikolaos, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01409850
First received: August 3, 2011
Last updated: December 2, 2014
Last verified: December 2014
  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
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 ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 3, 2011
Last Updated: December 2, 2014
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on December 02, 2016