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

NCT01409850 | Terminated

• 1 other identifier: UHeidelberg
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myofascial Pain

Outcome Measures

Primary Outcomes (1)

• Pain

  2-3 weeks

Secondary Outcomes (1)

• mouth opening

  2-3 weeks

Study Arms (3)

Aqualizer

ACTIVE COMPARATOR

Device: Aqualizer

Soft splint

ACTIVE COMPARATOR

elastic splint made of copolyester foil

Device: Soft splint

Counselling

NO INTERVENTION

Interventions

Aqualizer DEVICE

The Aqualizer is a soft splint with water-filled pads.

Aqualizer

Soft splint DEVICE

Soft splint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, non-chronic orofacial pain

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Department of Prosthodontics, University Clinic of Heidelberg

Heidelberg, Baden-Wurttemberg, D-69120, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.dent.,MSc

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: August 4, 2011
• Study Start: July 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

DE (1)