Effects of a Training Oral Device (Custom Splint) Adjusted Using Electromyography for the Balance Between the Masseter and Temporal Muscle in Elite Military Paratroopers.

April 9, 2026 updated by: Carlos Pérez-Albacete Martínez, Universidad Católica San Antonio de Murcia

Comparative Study in Professional Paratroopers Between Occlusion and Postural Condition

The aim of this prospective, longitudinal observational study is to evaluate the influence of the use of sports splints on the muscular activity of the stomatognathic system and cervical mobility in adult sport parachutists.

The main research questions are: Does the use of a sports splint modify the electromyographic activity of the masticatory muscles during functional movements? Does it produce changes measurable by accelerometry?

The researchers will compare the records obtained with and without the sports splint in order to determine whether the use of this device produces changes in the neuromuscular activity of the stomatognathic system and in cervical mobility.

Participants will perform the following tasks during the evaluation:

Recording of electromyographic activity of the masticatory muscles using surface electromyography.

Measurement of cervical movements using an accelerometer. Performance of functional cervical movements (flexion, extension, lateral inclination, and nodding) under conditions with and without the sports splint.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • Murcia, Murcia, Spain, 30008
        • UCAM DENTAL Av. Juan Carlos I 30008 Murcia (en el CC ZigZag)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Athletes aged 18 years or older
  • good oral health -no history of cardiovascular disease or diabetes -
  • oral hygiene habits of at least two brushings per day.

Exclusion Criteria:

Poor oral hygiene periodontitis history of recent dental trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Condición "splint-off" Condición "splint-on"
Each participant acted as their own control, with EMG recorded without and with the sports splint.
Diagnostic test: Effects of a Training Oral Device (Custom Splint) Adjusted Using Electromyography
Electromyographic recording comparing muscle activity with and without a sports splint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POC TA
Time Frame: 2 year
Percentage of Overlapping Coefficient of the Anterior Temporalis (right and left): A parameter that measures the degree of overlap in electromyographic activity between two muscles or between two conditions, used to assess muscular coordination or symmetry. The higher the percentage, the more synchronized or similar the muscular activity.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

August 10, 2025

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CE112008 (Other Identifier: UCAM University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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