Comparison of three methods for treatment of temporomandibular disorders
| ISRCTN | ISRCTN11741051 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11741051 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Rutgers, The State University of New Jersey |
| Funder | Rutgers, The State University of New Jersey |
- Submission date
- 14/09/2024
- Registration date
- 13/11/2024
- Last edited
- 06/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Temporomandibular disorders (TMD) encompass a range of conditions affecting the temporomandibular joint (TMJ) and associated musculature, characterized by pain and dysfunction during jaw movement. TMD ranks among the most prevalent musculoskeletal disorders globally, following closely behind low back pain. Its impact extends beyond localized symptoms, often involving chronic pain and comorbidities such as depression and migraines, significantly compromising quality of life. The disorder predominantly affects individuals aged 20-40 years, with a higher prevalence among women. The economic burden associated with TMD is substantial, reflecting its complex symptomatology and prolonged treatment requirements. Etiologically, TMD is multifactorial, influenced by factors ranging from trauma and stress to genetic predispositions. Diagnostic approaches rely on clinical evaluation, with imaging techniques reserved for specific indications. Management strategies encompass conservative, minimally invasive, and invasive interventions, emphasizing evidence-based approaches tailored to individual patient needs. Despite various treatment modalities, achieving consensus on optimal management remains a challenge, underscoring the need for further research into effective therapeutic paradigms. The study aims to compare the effectiveness of different treatment regimens for pain-related TMD. The study will evaluate and compare the effectiveness of combined orthotic splint therapy and home care regimen versus each therapy individually. The goal is to determine if combined therapy is more effective than individual therapies in managing Pain-related TMD.
Who can participate?
Patients aged between 18 and 80 years old diagnosed with TMD with pain present for at least 3 months
What does the study involve?
Participants will be randomly assigned to one of three groups:
1. Combined regimen with Orthotic splint therapy and home care
2. Home care regimen only.
3. Orthotic splint therapy only.
Participants will undergo a thorough clinical examination based on DC/TMD criteria, and data will be collected over four visits. The study will measure pain intensity, muscle and joint pain levels, and range of motion.
What are the possible benefits and risks of participating?
Participants will benefit from a potential reduction in TMD-related pain, improvement in jaw function and increased understanding of effective treatment combinations for TMD. Participants are at risk of feeling discomfort or pain during the clinical examination and treatment process, and the potential for ineffectiveness or adverse reactions to the treatment modalities.
Where is the study run from?
The Center for Temporomandibular Disorder and Orofacial Pain, Department of Diagnostic Sciences, Rutgers School of Dental Medicine, USA
When is the study starting and how long is it expected to run for?
May 2018 to December 2024
Who is funding the study?
Department of Diagnostic Sciences, Rutgers School of Dental Medicine, USA
Who is the main contact?
Gary M. Heir, DMD, (Department of Diagnostic Sciences, Rutgers School of Dental Medicine), heirgm@sdm.rutgers.edu
Contact information
Public, Scientific, Principal investigator
Department of Diagnostic Sciences
Rutgers School of Dental Medicine
110 Bergen Street, Room D-805
P.O Box 1709
Newark
07103
United States of America
 ORCID ID |
0000-0001-9571-402X |
|---|---|
| Phone | +1 973-972-6460 |
| heirgm@sdm.rutgers.edu |
Public, Scientific
Department of Diagnostic Sciences
Rutgers School of Dental Medicine
110 Bergen Street, Room D-805
P.O Box 1709
Newark, NJ 07103-1709
Newark
07103
United States of America
| ORCID ID |
0000-0003-3651-1286 |
|---|---|
| Phone | +1 (973) 972-318 |
| nasrici@sdm.rutgers.edu |
Scientific
Department of Diagnostic Sciences
Rutgers School of Dental Medicine
110 Bergen Street
Newark
07103
United States of America
| ORCID ID |
0000-0003-4261-9891 |
|---|---|
| Phone | +1 (973) 972-3418 |
| ananths1@sdm.rutgers.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of three methods for treatment of temporomandibular disorders |
| Study objectives | TMD patients managed with combined treatment (orthotic splints AND home care regimen) demonstrate maximum improvement compared to individual therapy (orthotic splints vs home care) |
| Ethics approval(s) |
Approved 26/09/2018, Rutgers Health Sciences IRB - Newark (65 Bergen St Suite 511, Newark, 07107, United States of America; +1 973-972-36608; IRBOffice@research.rutgers.edu), ref: Pro2018001261 |
| Health condition(s) or problem(s) studied | Treatment of temporomandibular disorders with non-invasive interventions |
| Intervention | The patients will be randomized using a computer-generated random allocation sequence into 3 different groups: Group 1: Combined regimen with Orthotic splint therapy AND home care instructions Group 2: Home care regimen only Group 3: Orthotic splint therapy only |
| Intervention type | Mixed |
| Primary outcome measure(s) |
1. Pain levels measured using a Visual Analogue Scale (VAS) at Baseline (V0) and all follow up visits at 2 weeks, 4 weeks, 6 weeks and 3 months (V1, V2, V3, V4) |
| Key secondary outcome measure(s) |
Rescue medication use measured using Rescue medication questionnaire at all follow up visits, 2 weeks, 4 weeks, 6 weeks and 3 months (V1, V2, V3, V4) |
| Completion date | 23/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 98 |
| Key inclusion criteria | 1. Patients diagnosed with TMD based on DC/TMD criteria with symptoms consistent with myalgia, myofascial pain with/without a referral, arthralgia and/or a combination of the above 2. Pain present for at least 3 months 3. 18-80 years old 4. Male/Female 5. Patients should have functional occlusion with posterior teeth support. |
| Key exclusion criteria | 1. The presence of comorbid systemic disease which can alter pain perception such as generalized muscle/joint or chronic pain disorders such as fibromyalgia, rheumatoid arthritis, Lyme disease, Osteoarthritis, idiopathic condylar resorption. 2. Subjects using chronic pain medications. 3. Subjects with cognitive problems that can result in an inability to follow instructions. If the patient has any disorders such as Down's syndrome or Alzheimer disease will be excluded from the study. |
| Date of first enrolment | 28/09/2018 |
| Date of final enrolment | 10/12/2024 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Newark
07103
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository (Rutgers School of Dental Medicine) The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request: Dr. Cibele Nasri-Heir (nasrici@sdm.rutgers.edu) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/11/2024: Study's existence confirmed by Rutgers Health Sciences IRB - Newark.
