NCT07699263

Brief 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 activation. This study evaluated the effect of a customized occlusal splint on the increase of Concurrent Activation Potentiation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

June 23, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

athletic performance and the impact on performance factors

Outcome Measures

Primary Outcomes (1)

  • 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

    Measurements were taken during the training sessions, in day 1

Secondary Outcomes (1)

  • Stroke efficiency

    Measurements were taken during the training sessions, in day 1

Other Outcomes (2)

  • Cardiovascular efficiency

    Measurements were taken during the training sessions, in day 1

  • Maximum heart rate

    Measurements were taken during the training sessions, in day 1

Study Arms (2)

intervention group, which used a customized occlusal splint

OTHER

intervention group, which used a customized occlusal splint

Other: occlusal splint

control group, which continued training without a splint

OTHER

control group, which continued training without a splint

Other: occlusal splint

Interventions

occlusal Splint

control group, which continued training without a splintintervention group, which used a customized occlusal splint

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • (It won't let me add the flowchart image, so I'll describe it below)
  • Participamos assessed for eligibility (n=24)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Europea de Valencia

Valencia, 46003, Spain

Location

MeSH Terms

Interventions

Occlusal Splints

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Oral Surgery

Study Record Dates

First Submitted

June 23, 2026

First Posted

July 13, 2026

Study Start

December 1, 2025

Primary Completion

April 30, 2026

Study Completion

May 24, 2026

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations