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

Myofascial Pain Clinical Trial

Official title:

Pilot Clinical Trial on the Treatment Effectiveness of Two Splints for Acute Temporomandibular Pain.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01409850
• Other study ID #: UHeidelberg
• Status: Terminated
• Phase: N/A
• First received: August 3, 2011
• Last updated: December 2, 2014
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myofascial Pain

Intervention

Device:
• Aqualizer
The Aqualizer is a soft splint with water-filled pads.
• Soft splint

Locations

Country	Name	City	State
Germany	Department of Prosthodontics, University Clinic of Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		2-3 weeks	No
Secondary	mouth opening		2-3 weeks	No