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

Heidelberg University

Status: Terminated

Conditions: Myofascial Pain

Treatments: Device: Soft splint; Device: Aqualizer

Study type: Interventional

Funder types: Other

Identifiers

NCT01409850

UHeidelberg

Details and patient eligibility

About

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).

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

36 participants in 3 patient groups

Aqualizer

Active Comparator group

Treatment:

Device: Aqualizer

Soft splint

Active Comparator group

Description:

elastic splint made of copolyester foil

Treatment:

Device: Soft splint

Counselling

No Intervention group