Hard Splint Vs Conservative Therapy for TMJ Pain Management

NCT07573137 | Not Yet Recruiting

• 1 other identifier: DSG_2022_019_4037
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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), over a period of 6 months.

Conditions

Temporomandibular Disorders (TMDs)

Keywords

Hard Occlusal splint; Conservative therapy; Visual Analogue Scale; Facial pain

Outcome Measures

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.

  baseline and 6 months.

Study Arms (2)

Hard Oclussal Splint

EXPERIMENTAL

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.

Device: Hard occlusal splint

Conservative Therapy

ACTIVE COMPARATOR

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).

Other: Counseling and Habit Modification; Drug: Topical Ibuprofen gel

Interventions

Hard occlusal splint DEVICE

A custom fabricated heat cure acrylic resin splint

Hard Oclussal Splint

Counseling and Habit Modification OTHER

Counseling regarding soft diet and avoidance of wide mouth opening.

Conservative Therapy

Topical Ibuprofen gel DRUG

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

Conservative Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with TMJ disorders based on clinical examination. Patients willing to participate and provide informed consent.

You may not qualify if:

• Patient with a history of recent TMJ surgery or trauma. Patients with systemic joint diseases (e.g Rheumatoid Arthritis). Patients currently using other occlusal appliances or undergoing active orthodontic treatment.

Sponsors & Collaborators

• Khyber College of dentistry: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Facial Pain

Interventions

Counseling

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FCPS Trainee, Department of Prosthodontics

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05