NCT07523984

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.7 years

First QC Date

March 19, 2026

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • POC TA

    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

Study Arms (1)

Condición "splint-off" Condición "splint-on"

ACTIVE COMPARATOR

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

Interventions

Electromyographic recording comparing muscle activity with and without a sports splint.

Condición "splint-off" Condición "splint-on"

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Poor oral hygiene periodontitis history of recent dental trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Murcia, Murcia, 30008, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigador principal

Study Record Dates

First Submitted

March 19, 2026

First Posted

April 13, 2026

Study Start

December 1, 2020

Primary Completion

August 10, 2025

Study Completion

February 28, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations