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NCT Number: NCT07573137

Hard Splint Vs Conservative Therapy for TMJ Pain Management

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.

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Key information

Conditions

Temporomandibular Disorders (TMDs) Craniomandibular Disorders Facial Pain Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hard occlusal splint

Device

A custom fabricated heat cure acrylic resin splint

Counseling and Habit Modification

Other

Counseling regarding soft diet and avoidance of wide mouth opening.

Topical Ibuprofen gel

Drug

5% Ibuprofen gel applied three times daily over the affected TMJ area.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Khyber College of dentistry

Other

Registry information

Official study title

Efficacy of Hard Splint Vs Conservative Therapy in the Pain Management of Temporomandibular Joint Disorders

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 7, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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