Effects of Occlusal Splint vs Occlusal Splint Added to Manual Therapy in Patients With Temporomandibular Disorders

NCT06859138 | Completed

• 1 other identifier: MTvsOS
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial evaluates physiotherapy plus splint treatment versus conventional splint treatment in patients with myofascial-origin temporomandibular disorder (TMD). The study follows the ethical principles of the Declaration of Helsinki and has been approved by the Research Ethics Committee of the University of Jaén. Methodology Participants, recruited from three dental clinics in Spain, must be adults diagnosed with TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD). Patients with health conditions that could hinder participation are excluded. They are randomly assigned to two groups: one receiving physiotherapy plus a splint, and the other receiving only a splint. The sample size was calculated using G\*Power, determining that at least 38 patients (19 per group) are required. Assessments and Measurements Sociodemographic variables include age, sex, BMI, education level, and lifestyle habits. Various instruments are used to assess TMD and pain, such as the DC/TMD, the Fonseca Anamnestic Index, the Numerical Pain Rating Scale, and the Neck Disability Index. Intervention Physiotherapy + splint group: Four 20-minute manual therapy sessions, including techniques for the temporomandibular joint and cervical muscles. Splint-only group: Only splint use as prescribed by the dentist. Assessments are conducted before and after treatment for the physiotherapy group and at two time points for the splint-only group (before splint placement and one month later). Data Analysis SPSS and MedCalc software will be used, with a 95% confidence level. Relationships will be analyzed through regression and Pearson correlation, and group comparisons will be performed using repeated measures ANOVA, Student's t-test, and Chi-square test. Effect size will be calculated using Cohen's d. In conclusion, the study aims to determine the effectiveness of combined physiotherapy and splint treatment compared to splint-only treatment in patients with myofascial TMD.

Conditions

Temporomandibular Disorders (TMD)

Keywords

temporomandibular disorders; manual therapy; splint therapy; occlusal splint

Outcome Measures

Primary Outcomes (3)

• Self reported Temporomandibular Functionning

  -Fonseca Anamnestic Index: self reported questionnaire about tamporomandibular symptoms.

  From the enrollment to end of treatment at one month

• Mouth opening

  Maximum mouth opening in millimeters

  From enrollment to the end of treatment at one month

• Temporomandibular functioning

  -Helkimo Clinical Dysfunction Index: temporomandibular symptoms index to be fulfilled by evaluator.

  From enrollment to the end of treatment at one month

Secondary Outcomes (3)

• Cervical function

  From enrollment to the end of treatment at one month

• Pain in temporomandibular joint

  From enrollment to the end of treatment at one month

• Headache or Cephalea

  From enrollment to the end of treatment at one month

Study Arms (2)

Manual therapy and splint therapy

EXPERIMENTAL

Intervention based on manual therapy techniques and splint therapy

Other: Manual Therapy; Other: Splint therapy

Splint therapy alone

ACTIVE COMPARATOR

Intervention based on splint therapy

Other: Splint therapy

Interventions

Manual Therapy OTHER

Manual therapy techniques including massage, trigger point pressure, muscle stretching and joint mobilization.

Manual therapy and splint therapy

Splint therapy OTHER

Dental splint used for temotoromandibular disorders treatment

Manual therapy and splint therapy; Splint therapy alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with myofascial temporomandibular disorders according to DC/TMD criteria.
• Participants over 18 years old (local legal age).

You may not qualify if:

• Participants unable to understand the questionnaires and assessments required for the study due to any condition.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Clinica Villa Aragón

Úbeda, Spain, 23400, Spain

Location

Related Publications (3)

• Villar-Aragon-Berzosa V, Obrero-Gaitan E, Lerida-Ortega MA, Lopez-Ruiz MDC, Rodriguez-Almagro D, Achalandabaso-Ochoa A, Molina-Ortega FJ, Ibanez-Vera AJ. Manual Therapy Techniques Versus Occlusal Splint Therapy for Temporomandibular Disorders: A Systematic Review with Meta-Analysis. Dent J (Basel). 2024 Nov 1;12(11):355. doi: 10.3390/dj12110355.

  PMID: 39590405 BACKGROUND

• Oliveira-Campelo NM, Rubens-Rebelatto J, Marti N-Vallejo FJ, Alburquerque-Sendi N F, Fernandez-de-Las-Penas C. The immediate effects of atlanto-occipital joint manipulation and suboccipital muscle inhibition technique on active mouth opening and pressure pain sensitivity over latent myofascial trigger points in the masticatory muscles. J Orthop Sports Phys Ther. 2010 May;40(5):310-7. doi: 10.2519/jospt.2010.3257.

  PMID: 20436241 BACKGROUND

• La Touche R, Fernandez-de-las-Penas C, Fernandez-Carnero J, Escalante K, Angulo-Diaz-Parreno S, Paris-Alemany A, Cleland JA. The effects of manual therapy and exercise directed at the cervical spine on pain and pressure pain sensitivity in patients with myofascial temporomandibular disorders. J Oral Rehabil. 2009 Sep;36(9):644-52. doi: 10.1111/j.1365-2842.2009.01980.x. Epub 2009 Jul 14.

  PMID: 19627454 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD IN Physiotherapy, Full Professor

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 5, 2025
• Study Start: March 6, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From the publication of the manuscript about the study report until with no end date.
• Access Criteria: Any request by email will be attended, as well as everybody could access to RUJA repository as it is public. For access, people will have to request by email or access to www.ruja.es

Locations

ES (1)