- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07716631
Effects of a Thermoformable Mouthguard on Cervical Posture and Running Performance in Non-professional Runners
July 23, 2026 updated by: Juan Antonio Blaya, Universidad Europea de Valencia
Effects of a Thermoformable Mouthguard on Cervical Posture and Running Performance in Non-professional Runners : A Prospective Within-subject Pilot Study
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
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
-
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Valencia
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Valencia, Valencia, Spain, 46003
- Universidad Europea de Valencia
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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
Accepts Healthy Volunteers
Yes
Description
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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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)
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: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Voluntarily participation
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Measurements were taken during the training sessions (Day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Measurements were taken during the training sessions (Day 1)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Measurements were taken during the training sessions (Day 1)
|
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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
|
Measurementes were taken during the training sessions (Day 1)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Maria del Carmen Ferrer Serena, Universidad Europea de Valencia
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)
October 1, 2025
Primary Completion (Actual)
April 18, 2026
Study Completion (Actual)
May 25, 2026
Study Registration Dates
First Submitted
July 16, 2026
First Submitted That Met QC Criteria
July 16, 2026
First Posted (Actual)
July 21, 2026
Study Record Updates
Last Update Posted (Actual)
July 27, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-520/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.