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

NCT07716631 — Not applicable, Completed, 10 participants, Universidad Europea de Valencia

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

RegistryNCT07716631
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, screening
Enrollment10 (Actual)
SponsorUniversidad Europea de Valencia (Other)
ConditionsHeart Rate, Craniovertebral Angle, Posture, Occlusal Mouthguards
InterventionsThermoformable mouthguard (Other)
Datesstart 2025-10-01, primary completion 2026-04-18, completion 2026-05-25, first posted 2026-07-21, last updated 2026-07-27
Locations1 site in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Heart Rate All trials for Craniovertebral Angle All trials of Thermoformable mouthguard

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Voluntarily participationOtherOther: Thermoformable mouthguardParticipants were recruited by convenience sampling among eligible students enrolled in dentistry and physiotherapy programmes at the Universidad Europea de Valencia between October and November 2025. All participants were invited to participate voluntarily and were included only after meeting the eligibility criteria and providing written informed consent.
  • 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.

+Outcome measures

Primary outcomes

  • Effects on cervical posture (CVA) [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

  • Heart Rate [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

  • Respiratory rate [Measurements were taken during the training sessions (Day 1)]: It was measured to assess whether the mouthguard influenced ventilatory patterns during running.
  • Running Speed [Measurementes were taken during the training sessions (Day 1)]: Speed was monitored to quantify running performance and compare both occlusal conditions

+Eligibility

Sex: All, ages: 18 Years to 25 Years, accepts healthy volunteers

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

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1. 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)
2. 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)
3. Analysis - Participants included in the final analysis (n = 9)

+Locations (1)

FacilityCityCountryStatus
Universidad Europea de ValenciaValencia, ValenciaSpain

+Investigators

  • Maria del Carmen Ferrer Serena, Study director, Universidad Europea de Valencia