CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
Botulinum toxin type A +1 moredrug
Likely dose
Botulinum toxin type A 0.1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03891121
NCT03891121N/ACompleted
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Which One is Effective in Treatment of Bruxism? Occlusal Splints or Botulinum Toxin

Ankara University·interventional·Posted Mar 26, 2019·Updated Mar 26, 2019

In Brief

A clinical study evaluating Occlusal Splint and Botulinum toxin type A for Myofascial Pain and Temporomandibular Disorder. Completed, enrolled 73 participants across 1 site.

Detailed Summary

73 patients with myofascial pain due to bruxism were included in this study. The patient were allocated into three groups. Group A was treated with occlusal splint, Group B was treated with botulinum toxin injection, Group C was treated with occlusal splint and botulinum toxin injection together. Temporomandibular Disorder Pain Screener (TMD-PS), Graded Chronic Pain Scale (GCPS), Oral Behavior Checklist (OBC), Jaw Function Limitation Scale (JFLS), Visual Analog Scale (VAS) by palpation of the chewing muscles were administered to all patients before treatment and at 6 months after treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyofascial Pain, Temporomandibular Disorder
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 26, 2019
Enrollment StartApr 5, 2018
Primary CompletionFeb 15, 2019
Study CompletionMar 10, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.3 years ago

Interventions

Occlusal Splintdevice

Occlusal splints are appliances that were usually applied to the upper jaw and covering all teeth and they are made of autopolymerizing acrylic resin. It is produced by using 2 mm thick hard acrylic between the maxilla and mandible as defined by the Okeson.

Botulinum toxin type Adrug

We diluted 100-U freeze-dried BTX-A with 1.0 milliliters of sodium chloride, resulting in a dose of 1.0 U per 0.1 mL. We administered all skin injections by using a 1-inch 30-gauge needle. Patients were placed with the Frankfurt horizontal plane parallel to the floor.