Actively Recruiting
Sport Mouthguards: Devices for Preventing Dental Injuries in Sports
Led by Universidade Federal do Rio de Janeiro · Updated on 2025-04-04
136
Participants Needed
1
Research Sites
81 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
Objective: To evaluate the impact of mouthguards (MG) on acceptability, incidence of soft tissue injuries, periodontal and salivary parameters, as well as on the perception of the body in sports practice (PeCoPes) and on the quality of life of athletes, and evaluate the consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself. Methodology: This is a longitudinal study that will include children, adolescents, and adults aged 7 to 30 years who practice sports and require MGs. Sociodemographic data, medical history, dental history, dietary habits, and sports practice data will be collected. Participants will undergo a complete oral clinical examination. Data on knowledge of traumatic dental injuries (TDI) and MGs will also be collected. Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use, the following parameters will be evaluated: presence of mucosal injuries, visible plaque index, gingival bleeding index, salivary flow, salivary pH, buffering capacity, and salivary microorganism count. Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use. PeCoPes and quality of life will be assessed before, 1, 3, and 6 months after MG use. The MG will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status. The data will be tabulated and analyzed using SPSS 21.0, and appropriate statistical tests (p\<0.05) will be performed according to the study objectives.
CONDITIONS
Official 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
- Practice sports at least twice a week
You will not qualify if you...
- Have cavitated dental caries and/or periodontitis
- Have Angle Class III malocclusion with negative anterior overjet
- Have non-removable prostheses or accessories in upper or lower dental arches affecting mouthguard fitting
- Use medications that may interfere with salivary parameters
- Have neurological disorders or communication difficulties
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here