Heart RateNCT07716631
Effects of a Thermoformable Mouthguard on Cervical Posture and Running Performance in Non-professional Runners
A study testing Thermoformable mouthguard in people with Heart Rate and Craniovertebral Angle, run by Universidad Europea de Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate, Craniovertebral Angle, Posture
- What is being tested?
- Thermoformable mouthguard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to 25 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Rate, Craniovertebral Angle, Posture, Occlusal Mouthguards
- Being tested
- Thermoformable mouthguard
- Keywords
- Mouthguard, Posture, Craniovertebral angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoformable mouthguardOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Thermoformable mouthguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements were taken during the training sessions (Day 1)
Secondary outcomes (1)
Heart Rate
It was recorded during the running test to evaluate the cardiovascular response under each occlusal condition.
Measured: Measurements were taken during the training sessions (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Oct 2025
- Primary completion18 Apr 2026
- Study completion25 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Antonio Blaya, Universidad Europea de Valencia
- Investigators
- Maria del Carmen Ferrer Serena, Study director, Universidad Europea de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716631
- Sponsor's protocol ID
- 2024-520/1
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Thermoformable Mouthguard on Cervical Posture and Running Performance in Non-professional Runners : A Prospective Within-subject Pilot Study
- ClinicalTrials.gov ID
- NCT07716631
- Acronym / sponsor ID
- 2024-520/1
- Conditions
- Heart Rate, Craniovertebral Angle, Posture, Occlusal Mouthguards
- Keywords
- Mouthguard, Posture, Craniovertebral angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad Europea de ValenciaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 18 Apr 2026 (actual)
- Study completion
- 25 May 2026 (actual)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Voluntarily participation | Other | Other: 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermoformable mouthguardThe 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. | Other | Voluntarily participation |
Primary outcome
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.
1 secondary outcome
Heart Rate
Time frame: Measurements were taken during the training sessions (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria del Carmen Ferrer Serena study director
Universidad Europea de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoformable mouthguard in people with Heart Rate and Craniovertebral Angle, run by Universidad Europea de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on cervical posture (CVA) (time frame: Measurements were taken during the training sessions (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.