Efficacy of Hard Splint Vs Conservative Therapy in the Pain Management of Temporomandibular Joint Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- Pain Intensity
Study Overview
Brief Summary
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.
Detailed Description
This randomized controlled trial will be conducted at the department of Prosthodontics, Khyber College of Dentistry, Peshawar. Patients diagnosed with TMJ disorders based on clinical examination will be randomly assigned to two groups.
GROUP A: Patients will receive a hard occlusal splint made of heat cure acrylic resin to be worn at night.
GROUP B: Patients will receive conservative therapy consisting of topical 5% Ibuprofen gel application three times daily and counseling regarding habit modification(soft diet ,avoiding wide mouth opening).
Pain intensity will be recorded for both groups at baseline , 1 week and 4 week followup visit using a 10cm Visual Analogue Scale. the data will be analyzed using SPSS version 22.0.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with TMJ disorders based on clinical examination. Patients willing to participate and provide informed consent.
Exclusion Criteria
- •Patient with a history of recent TMJ surgery or trauma. Patients with systemic joint diseases (e.g Rheumatoid Arthritis, Osteoporosis, Osteopetrosis, Osteomalacia).
- •Patients currently using other occlusal appliances or undergoing active orthodontic treatment.
Arms & Interventions
Hard Oclussal Splint
Patients in this group will be provided with hard occlusal splint made of heat cure acrylic resin, to be worn at night for a duration of 6 months.
Intervention: Hard occlusal splint (Device)
Conservative Therapy
Patients in this group will receive conservative management consisting of topical 5% Ibuprofen gel applied three times daily and counseling regarding habit modification (soft diet, avoiding wide mouth opening).
Intervention: Counseling and Habit Modification (Other)
Conservative Therapy
Patients in this group will receive conservative management consisting of topical 5% Ibuprofen gel applied three times daily and counseling regarding habit modification (soft diet, avoiding wide mouth opening).
Intervention: Topical Ibuprofen gel (Drug)
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: baseline, 1 week and 4 weeks
Pain will be assessed using a 10cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents worst possible pain.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ayesha Urooj
FCPS Trainee, Department of Prosthodontics
Khyber College of dentistry