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Effect of Hard Labial Reinforcement of a Mouthguard on the Degree of Satisfaction Among Rugby Players

NCT05238480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-11-03

No results posted yet for this study

Summary

This study assesses the effect of incorporating a hard labial layer to the front zone of a custom-made mouthguard on the degree of satisfaction of rugby players. Twenty-four rugby players will wear a custom-made Bioplast Xtreme conventional mouthguard (Bioplast Xtreme 4 × 125 + Bioplast 2 x 125; Scheu-Dental Company) and a custom-made Bioplast Xtreme Pro mouthguard (Bioplast Xtreme 4mm × 125 + Duran Layer 0.75mm; Bioplast 2mm x 125), two weeks per mouthguard. They will wear it during training sessions and competitions. The sequence will be randomized for one-half of the participants to start wearing the Bioplast Xtreme conventional and the other half the Bioplast Xtreme Pro mouthguard the first week.

The participants will rate the degree of interference with oral functions or discomfort in reference to speeking, breathing, swallowing, gag reflex, tight or loose fitting, aesthetics and athletic performance, in a 10-point scale, considering 0 no discomfort/interference and 10 maximum discomfort/interference. After each session, players will also rate the perception of the protection, the degree of improvement on athletic performance and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.

Conditions

  • Satisfaction
  • Quality of Life

Interventions

DEVICE

XC mouthguard

Use of a Xtreme Conventional custom-made mouthguard while playing rugby

DEVICE

XP mouthguard

Use of a Xtreme Pro custom-made mouthguard while playing rugby

Sponsors & Collaborators

  • University of Barcelona

    lead OTHER

Principal Investigators

  • Jordi Martinez-Gomis, DDS PhD · University of Barcelona

  • Jordi Martinez-Gomis, DDS PhD · University of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-05-31
Completion
2022-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05238480 on ClinicalTrials.gov