Temporomandibular Disorders (TMDs)NCT07573137
Hard Splint Vs Conservative Therapy for TMJ Pain Management
A study testing Hard occlusal splint, Counseling and Habit Modification and Topical Ibuprofen gel in people with Temporomandibular Disorders (TMDs), run by Khyber College of dentistry.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorders (TMDs)
- What is being tested?
- Hard occlusal splint, Counseling and Habit Modification and Topical Ibuprofen gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with TMJ disorders based on clinical examination. Patients willing to participate and provide informed consent.
Who cannot join
- 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.
About this study
Official title: Efficacy of Hard Splint Vs Conservative Therapy in the Pain Management of Temporomandibular Joint Disorders
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.
Read the 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.
- Conditions
- Temporomandibular Disorders (TMDs)
- Being tested
- Hard occlusal splint, Counseling and Habit Modification, Topical Ibuprofen gel
- Keywords
- Hard Occlusal splint, Conservative therapy, Visual Analogue Scale, Facial pain
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hard occlusal splintDevice
A custom fabricated heat cure acrylic resin splint
Counseling and Habit ModificationOther
Counseling regarding soft diet and avoidance of wide mouth opening.
Topical Ibuprofen gelDrug
5% Ibuprofen gel applied three times daily over the affected TMJ area.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Counseling and Habit Modification; Drug: Topical Ibuprofen gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain will be assessed using a 10cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents worst possible pain.
Measured: baseline, 1 week and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMDs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber College of dentistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Urooj, Khyber College of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573137
- Sponsor's protocol ID
- DSG_2022_019_4037
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hard Splint Vs Conservative Therapy in the Pain Management of Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT07573137
- Acronym / sponsor ID
- DSG_2022_019_4037
- Conditions
- Temporomandibular Disorders (TMDs)
- Keywords
- Hard Occlusal splint, Conservative therapy, Visual Analogue Scale, Facial pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khyber College of dentistryUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hard Oclussal Splint | Experimental | Device: Hard occlusal splintPatients 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. |
| Conservative Therapy | Active comparator | Other: Counseling and Habit Modification, Drug: Topical Ibuprofen gelPatients 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with TMJ disorders based on clinical examination. Patients willing to participate and provide informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hard occlusal splintA custom fabricated heat cure acrylic resin splint | Device | Hard Oclussal Splint |
| Counseling and Habit ModificationCounseling regarding soft diet and avoidance of wide mouth opening. | Other | Conservative Therapy |
| Topical Ibuprofen gel5% Ibuprofen gel applied three times daily over the affected TMJ area. | Drug | Conservative Therapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Related trials for Temporomandibular Disorders (TMDs)
RecruitingObservational study
Spinal Mobility, Rigidity, and Kinesiophobia in PD and TMD
PARKINSON DISEASE (Disorder), Rigidity
Not yet recruiting
Effects of Orofascial Myofunctional Therapy and Cervical Stabilization Exercises on Temporomandibular Dysfunction
Temporomandibular Disorders (TMDs), Temporo-mandibular Dysfunction
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Not yet recruiting
Comparison of Conventional,3D Printed and Novel Hybrid Stabilization Splints in the Management of Temporomandibular Joint Disorders
Temporomandibular Disorders (TMDs), Myofascial Pain - Dysfunction Syndrome of TMJ
Not yet recruitingObservational study
The Italian Version of the Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)
Temporomandibular Disorders (TMDs), Kinesiophobia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hard occlusal splint, Counseling and Habit Modification and Topical Ibuprofen gel in people with Temporomandibular Disorders (TMDs), run by Khyber College of dentistry.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: baseline, 1 week and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.