Actively Recruiting
Sport Mouthguards: Devices for Preventing Dental and Alveolar Injuries in Sports - A Longitudinal Study
Led by Universidade Federal do Rio de Janeiro · Updated on 2025-04-04
136
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
Universidade Federal do Rio de Janeiro
Lead Sponsor
C
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the impact of sport mouthguards on athletes aged 7 to 30 years who regularly practice sports. The study aims to assess how mouthguards affect acceptability, incidence of soft tissue injuries, periodontal and salivary health, body perception during sports, and quality of life. Additionally, it evaluates how the mouthguards themselves change over time in terms of physical, biological, and conservation properties. Participants will receive a custom-made sport mouthguard created from two 3mm vinyl acetate ethylene sheets designed for trauma prevention and comfort. After an initial clinical examination and dental impressions, the mouthguard will be delivered and used by participants. Follow-up evaluations will occur at 1, 3, and 6 months to monitor oral health, injuries, and mouthguard condition. During the study, participants will undergo oral examinations and provide data on medical and dental history, diet, and sports activity. Researchers will measure mucosal injuries, plaque, gum bleeding, salivary flow and pH, buffering capacity, and microorganism counts before mouthguard use and at multiple follow-up points. Acceptability, body perception in sports, and quality of life will also be assessed at several intervals. The mouthguard’s bacterial contamination and physical changes will be tracked over six months.
CONDITIONS
Brief Title
Sport Mouthguards: Devices for Preventing Dental Injuries in Sports
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children, adolescents, and adults aged 7 to 30 years, with no systemic health issues, of both genders
- Engaging in sports practice at least twice a week
You will not qualify if you...
- Presence of cavitated dental caries and/or periodontitis
- Angle Class III malocclusion with negative anterior overjet
- Presence of non-removable prostheses or any other accessory in the upper or lower arch that may interfere with the adaptation of the mouthguard
- Use of medications that may interfere with any salivary parameters
- Children, adolescents, and adults with neurological disorders or communication difficulties
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for clinical examination and anamnesis
Duration - Initial fitting plus 6 months of use
Participants receive a custom-made sport mouthguard created from dental impressions to prevent dental injuries during sports.
1 visit for mouthguard fitting followed by visits at 1, 3, and 6 months
Trial Site Locations
Total: 1 location
1
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil, 21941-971
Actively Recruiting
Research Team
M
Mariana Pires da Costa, PhD Student
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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