the Aim of This Study Was to Evaluate the Effect of a Custom Occlusal Splint on Swimming Performance, Stroke Efficiency, and Heart Rate in Master SwimmersNCT07699263
Effect of an Occlusal Splint in Swimming Performance
A study testing occlusal splint in people with the Aim of This Study Was to Evaluate the Effect of a Custom Occlusal Splint on Swimming Performance, Stroke Efficiency, and Heart Rate in Master Swimmers and Athletic Performance and the Impact on Performance Factors, run by Universidad Europea de Valencia at 1 site in Spain.
Trial summary
Optimizing sports performance depends on the interaction of physiological, biomechanical, and neuromuscular factors. In recent years, interest has increased in the relationship between stomatognathic function and athletic performance, particularly regarding the possible role of occlusal splints in neuromuscular… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- the Aim of This Study Was to Evaluate the Effect of a Custom Occlusal Splint on Swimming Performance, Stroke Efficiency, and Heart Rate in Master Swimmers, Athletic Performance and the Impact on Performance Factors
- What is being tested?
- occlusal splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2025to 24 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
To be eligible for inclusion, participants had to be between 20 and 40 years of age, actively participating in regular swimming training, free from acute or chronic injuries, and willing to comply with the study protocol. Exclusion criteria included use of performance-enhancing substances, presence of systemic diseases, current use of medication affecting performance, active orthodontic appliances, temporomandibular joint disorders, pregnancy, or failure to complete the study protocol.
(It won't let me add the flowchart image, so I'll describe it below)
- Participamos assessed for eligibility (n=24)
- Excluded (n=4) 2.1 Did not Meet inclusion criteria (n=3) 2.2 Did not provide informed consent (n=1)
- Randomized (n=20) 3.1 Intervention group (case) (n=10) 3.1.1 Lost to follow-up (n=0) 3.1.2 Analyzed (n=10) 3.2 Control group (n=10) 3.2.1 Lost to follow-up (n=0) 3.2.2 Analyzed (n=10)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Customized Occlusal Splint on Athletic Performance in Master Swimmers: A Randomized Pilot Clinical Trial
Optimizing sports performance depends on the interaction of physiological, biomechanical, and neuromuscular factors. In recent years, interest has increased in the relationship between stomatognathic function and athletic performance, particularly regarding the possible role of occlusal splints in neuromuscular activation. This study evaluated the effect of a customized occlusal splint on the increase of Concurrent Activation Potentiation.
- Conditions
- the Aim of This Study Was to Evaluate the Effect of a Custom Occlusal Splint on Swimming Performance, Stroke Efficiency, and Heart Rate in Master Swimmers, Athletic Performance and the Impact on Performance Factors
- Being tested
- occlusal splint
- Keywords
- athletic performance and the impact on performance factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occlusal splintOther
occlusal Splint
| Study group | Role | What they receive |
|---|---|---|
| intervention group, which used a customized occlusal splint | Other | intervention group, which used a customized occlusal splint Receives: Other: occlusal splint |
| control group, which continued training without a splint | Other | control group, which continued training without a splint Receives: Other: occlusal splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
swimming performance
swimming performance was quantified as pace in 100 meters and 50 meters freestyle, both measured in seconds with a digital stopwatch (SRUIS, ZSD013, France). For each participant and distance, three consecutive trials were recorded under standardized conditions, and averaged for statistical analysis
Measured: Measurements were taken during the training sessions, in day 1
Secondary outcomes (1)
Stroke efficiency
Stroke efficiency was measured as the number of strokes per 25 meters, determined by direct observation and manual counting by two externals observers
Measured: Measurements were taken during the training sessions, in day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Dec 2025
- Primary completion30 Apr 2026
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Aim of This Study Was to Evaluate the Effect of a Custom Occlusal Splint on Swimming Performance, Stroke Efficiency, and Heart Rate in Master SwimmersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized pilot clinical trial was conducted with 20 master swimmers, allocated to an intervention group, which used a customized occlusal splint, and a control group, which continued training without a splint. The variables analysed were 100-meter freestyle pace, 50-meter freestyle pace, number of strokes per 25 meters, and heart rate. Measurements were performed at baseline and after 88 days of follow-up. Statistical analysis included non-parametric methods, the Brunner-Langer model, the Wilcoxon test, and the Mann-Whitney U test. Statistical significance was set at p \< 0.05.
- Masking
- None (open label)
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699263
- Sponsor's protocol ID
- 2024-520
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Customized Occlusal Splint on Athletic Performance in Master Swimmers: A Randomized Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT07699263
- Acronym / sponsor ID
- 2024-520
- Conditions
- the Aim of This Study Was to Evaluate the Effect of a Custom Occlusal Splint on Swimming Performance, Stroke Efficiency, and Heart Rate in Master Swimmers, Athletic Performance and the Impact on Performance Factors
- Keywords
- athletic performance and the impact on performance factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Europea de ValenciaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 13 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.
Optimizing sports performance depends on the interaction of physiological, biomechanical, and neuromuscular factors. In recent years, interest has increased in the relationship between stomatognathic function and athletic performance, particularly regarding the possible role of occlusal splints in neuromuscular activation. This study evaluated the effect of a customized occlusal splint on the increase of Concurrent Activation Potentiation.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized pilot clinical trial was conducted with 20 master swimmers, allocated to an intervention group, which used a customized occlusal splint, and a control group, which continued training without a splint. The variables analysed were 100-meter freestyle pace, 50-meter freestyle pace, number of strokes per 25 meters, and heart rate. Measurements were performed at baseline and after 88 days of follow-up. Statistical analysis included non-parametric methods, the Brunner-Langer model, the Wilcoxon test, and the Mann-Whitney U test. Statistical significance was set at p < 0.05.
| Arm | Type | Receives |
|---|---|---|
| intervention group, which used a customized occlusal splint | Other | Other: occlusal splintintervention group, which used a customized occlusal splint |
| control group, which continued training without a splint | Other | Other: occlusal splintcontrol group, which continued training without a splint |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| occlusal splintocclusal Splint | Other | control group, which continued training without a splint, intervention group, which used a customized occlusal splint |
Primary outcome
swimming performance
Time frame: Measurements were taken during the training sessions, in day 1
swimming performance was quantified as pace in 100 meters and 50 meters freestyle, both measured in seconds with a digital stopwatch (SRUIS, ZSD013, France). For each participant and distance, three consecutive trials were recorded under standardized conditions, and averaged for statistical analysis
1 secondary outcome
Stroke efficiency
Time frame: Measurements were taken during the training sessions, in 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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occlusal splint in people with the Aim of This Study Was to Evaluate the Effect of a Custom Occlusal Splint on Swimming Performance, Stroke Efficiency, and Heart Rate in Master Swimmers and Athletic Performance and the Impact on Performance Factors, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 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?
swimming performance (time frame: Measurements were taken during the training sessions, in 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 13 Jul 2026.