Temporomandibular Disorder
Conditions
Keywords
TMD
Brief summary
The goal of this clinical trial is to test analgesic effect of ECa 233 in subjects with TMD. The main questions it aims to answer are: * Can ECa 233 reduce pain intensity score in subjects with acute TMD? * Can ECa 233 increase jaw functional movements in subjects with acute TMD? Participants will be separated into four groups, including placebo, ibuprofen, low-dosed Eca and high-dosed Eca groups.
Detailed description
ECa 233 is a standardized extract of Centella asiatica with known anti-inflammatory properties and an acceptable safety profile. Hence, it would be relevant to evaluate the anti-inflammatory and pain reducing effects of ECa 233 on subjects with acute TMD, as well as jaw functional movements. A randomized, double-blind, placebo- and active-controlled clinical trial was performed on 18 to 50-year-old participants with acute TMD. These were randomly assigned to four treatment groups for 14 days: placebo, ibuprofen, ECa 233 250mg and 500 mg. At baseline, subjects reported 5 to 8 of pain intensity on a numerical rating scale (NRS). No medications were self-reported 24 h before and during the trial and no systemic conditions were diagnosed. Degenerative joint disease was screened before treatment. Pain intensity levels, mandibular range of motion including pain-free, unassisted and assisted mouth opening at baseline and days7 and 14 post-treatment. Masticatory muscle and jaw joint tenderness were evaluated upon palpation.
Interventions
DRUGECa 233
Intervention groups are separated into group A and group B. Group A takes capsules containing 250 mg of ECa 233 and group B takes capsules containing 500 mg of ECa 233.
DRUGIbuprofen
Ibuprofen group was given capsules containing 200 mg of ibuprofen
OTHERPlacebo
Placebo-controlled group received capsules containing 250 mg of lactose
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A randomized, double-blind, placebo- and active-controlled clinical trial was performed on 18 to 50-year-old participants with acute TMD. These were randomly assigned to four treatment groups for 14 days: placebo, ibuprofen, ECa 233 250mg and 500 mg. At baseline, subjects reported 5 to 8 (out of 10) of pain intensity on a numerical rating scale (NRS). No medications were self-reported 24 hours before and during the trial and no systemic conditions were diagnosed. Degenerative joint disease was screened before treatment. Pain intensity levels, mandibular range of motion including pain-free, unassisted and assisted mouth opening, were recorded at baseline and 7 and 14 days post-treatment. Masticatory muscle and jaw joint tenderness were evaluated upon palpation according to the Diagnostic Criteria for TMD (DC/TMD).
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Subjects reporting TMD pain lasting for 30 days or less (acute pain) * Subjects with pain ratings between 5 and 8 on a 0-10 numerical rating scale
Exclusion criteria
* Subjects with any underlying chronic disease * Subjects undergo any sort of treatment that may influence pain perception and/or inflammation, including as diabetes, psychological distress, systemic inflammatory disorders, oral appliances, and medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of ECa 233 for pain intensity | 14 days | The pain intensity self-reported levels and other clinical parameters were collected at 3 time points: pre-intervention (baseline), 7 and 14 days post-intervention. The pain intensity score was determined by using a 10-point ordinal scale (0 representing no pain and 10 indicating severe pain). |
| Efficacy of ECa 233 capsules for jaw function | 14 days | Mandibular range of motion, including pain-free, unassisted and assisted mouth opening, |
| Clinical efficacy of ECa 233 capsules in reducing areas of pain on palpation | 14 days | The number of masticatory muscles and TMJs with pain upon palpation were counted on the left and right sides. The total score ranged from 0-12 locations |
Countries
Thailand
Outcome results
None listed