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:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 12:57 AM
NCT ID:
NCT00471393
Eligibility Criteria:
Inclusion Criteria:
* A baseline score of ≥ 3.0 cm on a 10 cm measured VAS (Visual Analogue Scale) according to the criteria established by Collins et al. (Collins, Moore, \& Mcquay, 1997) (for moderate and severe pain) required for participants prior to use of analgesics, in order to provide adequate sensitivity.
* Females from the ages of 18 to 45 years of age inclusive.
* Primary degenerative joint disease as diagnosed through radiographs utilizing volumetric cone beam computed tomographic images reformatted in axial, coronal, and sagittal views that will be assessed by an independent radiologist.
Exclusion Criteria:
* Nursing or expectant females or females planning on becoming pregnant.
* Participants not clearly diagnosed as having symptomatic degenerative joint disease.
* Participants having DJD secondarily to trauma, previous infection or general joint/muscle disease.
* Participants who have experienced adverse reactions to any of the components of the formulation used in the study.
* Participants who have evidence of periodontal disease, dental caries, oral pathology or infections of the oral cavity.
* Participants with a history of neuropathic pain in the orofacial region.
* Participants scheduled for surgery in the near future.
* Participants currently undergoing orthodontic treatment.
* Participants with a history of epilepsy, cardiovascular disease, renal disease/disorder, hepatic disease/disorder, glaucoma, bowel obstruction, urinary retention, diabetes, hypertension or orthostatic hypotension.
* Participants with a malignancy.
* Participants who are currently using topical preparations for palliative relief for their DJD.
* Participants with a baseline intensity of ≤ 3/10 on the VAS.
* Inability to understand English.
* Participants who have been wearing an occlusal splint ≤ 3 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00471393
Study Brief:
Protocol Section:
NCT00471393