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Hard Splint Vs Conservative Therapy for TMJ Pain Management

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07573137
Enrollment
60
Registered
2026-05-07
Start date
2026-05-01
Completion date
2026-11-30
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorders (TMDs)

Keywords

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

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.

Interventions

A custom fabricated heat cure acrylic resin splint

OTHERCounseling and Habit Modification

Counseling regarding soft diet and avoidance of wide mouth opening.

DRUGTopical Ibuprofen gel

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

Sponsors

Khyber College of dentistry
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Intensitybaseline, 1 week and 4 weeksPain will be assessed using a 10cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents worst possible pain.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026