Hard Splint Vs Conservative Therapy for TMJ Pain Management
ConditionTemporomandibular Disorders (TMDs)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKhyber College of dentistry
About this trial
The purpose of this study is to compare the efficacy of a hard occlusal splint versus conservative therapy (using topical Ibuprofen gel and counseling) in the management of patients with temporomandibular (TMJ) joint disorders. The study aims to determine which treatment is more effective at reducing pain, measured by Visual Analogue Scale (VAS), at 1 week and 4 weeks post therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with TMJ disorders based on clinical examination. Patients willing to participate and provide informed consent.
Disqualifiers
Patient with a history of recent TMJ surgery or trauma. Patients with systemic joint diseases (e.g Rheumatoid Arthritis, Osteoporosis, Osteopetrosis, Osteomalacia).
Trial design
Design model
Parallel
Treatments tested in this trial
Hard occlusal splint
DeviceA custom fabricated heat cure acrylic resin splint
Counseling and Habit Modification
Other interventionCounseling regarding soft diet and avoidance of wide mouth opening.
Topical Ibuprofen gel
Drug5% Ibuprofen gel applied three times daily over the affected TMJ area.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Hard Oclussal SplintExperimental treatment 1 intervention
Group B: Conservative TherapyActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Pain Intensity
Pain will be assessed using a 10cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents worst possible pain.
Time frame
baseline, 1 week and 4 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: