Skip to main content
OpenTrials
Completed

NCT Number: NCT07716631

Effects of a Thermoformable Mouthguard on Cervical Posture and Running Performance in Non-professional Runners

The stomatognathic system is functionally connected to the overall body system. Occlusal modification using intraoral devices may therefore influence postural alignment and physiological responses during exercise. However, evidence regarding the combined effects of mouthguard use on cervical posture and running performance remains limited. This study evaluates the effects of a thermoformable mouthguard on craniovertebral angle, heart rate, respiratory rate and running performance in non-professional runners.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Europea de Valencia

Valencia, 46003, Spain

About this study

A prospective within-subject pilot study was conducted in nine non-professional runners. Each participant was assessed under two conditions : natural occlusion and thermoformable mouthguard. Static cervical posture was evaluated using the craniovertebral angle. Running performance was assessed recording heart rate, respiratory rate and running pace.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Students from Universidad Europea de Valencia enrolled in dentistry and physiotherapy programs, aged between 18 and 25 years
  • Regularly engaged in running training, with at least one year of experience
  • Already participated in an official half marathon
  • Good general health status
  • Willingness to comply with the study protocol and provision of written informed consent prior to participation

Exclusion criteria

  • Subjects reporting a history of muscular injuries, active inflammatory or infectious processes in the last 6 months
  • Known cardiovascular diseases
  • Pregnancy
  • Use of orthopedic shoe insoles
  • Use of mouthguard during running

As I am unable to upload the flow chart image, I have provided its content in text format below.

  • Recruitment
  • Participants assessed for eligibility (n = 17)
  • Excluded (n = 8):
  • Declined participation due to lack of time (n = 3)
  • Did not meet the inclusion criteria (n = 5)
  • Allocation and follow-up
  • Participants included in the study (n = 9)
  • Assigned to both conditions (within-subject design):
  • Natural occlusion condition (n = 9)
  • Thermoformable mouthguard condition (n = 9)
  • Completed follow-up (n = 9)
  • Analysis - Participants included in the final analysis (n = 9)

Treatment and study plan

Thermoformable mouthguard

Other

The intervention consisted of a thermoformable mouthguard individually adapted to each participant. The device used was the Domyos Adult Bi-Material Mouthguard (Decathlon, France), composed of high-density ethylene-vinyl acetate and styrene-ethylene-butadiene-styrene.

Primary outcomes

  1. Effects on cervical posture (CVA)

    Time frame: Measurements were taken during the training sessions (Day 1)

    The CVA served as the primary postural variable, reflecting head and cervical alignment. It was calculated from standardized photographs using the APECS system, based on the angle between a horizontal cervical reference line and a line extending from the tragion to the same point. Lower CVA values indicate a forward head posture.

Secondary outcomes

  1. Heart Rate

    Time frame: Measurements were taken during the training sessions (Day 1)

    It was recorded during the running test to evaluate the cardiovascular response under each occlusal condition.

Other outcomes

  1. Respiratory rate

    Time frame: Measurements were taken during the training sessions (Day 1)

    It was measured to assess whether the mouthguard influenced ventilatory patterns during running.

  2. Running Speed

    Time frame: Measurementes were taken during the training sessions (Day 1)

    Speed was monitored to quantify running performance and compare both occlusal conditions

Sponsors and collaborators

Lead sponsor

Universidad Europea de Valencia

Other

Registry information

Official study title

Effects of a Thermoformable Mouthguard on Cervical Posture and Running Performance in Non-professional Runners : A Prospective Within-subject Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.