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

NCT07716631 | Completed

• 1 other identifier: 2024-520/1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posture; Heart Rate; Craniovertebral Angle; Occlusal Mouthguards

Keywords

Mouthguard; Posture; Craniovertebral angle

Outcome Measures

Primary Outcomes (1)

• Effects on cervical posture (CVA)

  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.

  Measurements were taken during the training sessions (Day 1)

Secondary Outcomes (1)

• Heart Rate

  Measurements were taken during the training sessions (Day 1)

Other Outcomes (2)

• Respiratory rate

  Measurements were taken during the training sessions (Day 1)

• Running Speed

  Measurementes were taken during the training sessions (Day 1)

Study Arms (1)

Voluntarily participation

OTHER

Participants 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.

Other: Thermoformable mouthguard

Interventions

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.

Voluntarily participation

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Universidad Europea de Valencia: lead

Study Sites (1)

Universidad Europea de Valencia

Valencia, Valencia, 46003, Spain

Location

Study Officials

• Maria del Carmen Ferrer Serena

  Universidad Europea de Valencia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Oral Surgery

Model Details: A prospective within-subject pilot study was conducted in nine non-professional runners enrolled at the Universidad Europea de Valencia, Spain. Each participant was assessed under two conditions : natural occlusion and thermoformable mouthguard. Static cervical posture was evaluated using the craniovertebral angle measured from standardized lateral photographs with the APECS system. Running performance was assessed during four 5-km running sessions per condition recording heart rate, respiratory rate and running pace. Non-parametric statistical methods were performed, and associations between changes in posture and performance were explored using Spearman correlation coefficients.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: October 1, 2025
• Primary Completion: April 18, 2026
• Study Completion: May 25, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)