Hard Splint Vs Conservative Therapy for TMJ Pain Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hard occlusal splint, Counseling and Habit Modification, Topical Ibuprofen gel.
- Who it may be relevant to
- Registry conditions: Temporomandibular Disorders (TMDs). Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Hard Splint Vs Conservative Therapy in the Pain Management of Temporomandibular Joint Disorders
Overview
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.
Interventions
- Device Hard occlusal splint
A custom fabricated heat cure acrylic resin splint - Other Counseling and Habit Modification
Counseling regarding soft diet and avoidance of wide mouth opening. - Drug Topical Ibuprofen gel
5% Ibuprofen gel applied three times daily over the affected TMJ area.
Primary outcome measures
- Pain Intensity [Time frame: baseline, 1 week and 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07573137 · DSG_2022_019_4037