Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-24 @ 11:31 PM
NCT ID:
NCT06994156
Eligibility Criteria:
Inclusion Criteria
* Diagnosis of myalgia or myofascial pain with referral according to the DC/TMD Axis I
* Diagnosis of fibromyalgia according to ACR 1990 or ACR 2016 criteria
* Minimum pain intensity of 30 on a 100 mm visual analogue scale (VAS)
Exclusion Criteria
* Diagnosed systemic muscular or joint diseases (except for fibromyalgia)
* Whiplash-associated disorder
* Migraine
* Neurological disorders
* Neuropsychiatric disorders
* Diseases of the salivary glands (e.g., sialadenitis, salivary gland tumours)
* Pregnancy and lactation
* Obesity
* Use of analgesics within the last 24 hours
* Oral complaints such as oral dryness
* Mucosal lesions in the oral cavity
* Fewer than 22 natural teeth
* Extensive prosthodontic rehabilitations
* Poor oral hygiene
* Hyposalivation
* Oral diseases (periodontal diseases and mucosal pain or ulcerations)
* Extensive dental abrasion
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06994156
Study Brief:
Protocol Section:
NCT06994156