Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Not Applicable

Recruiting

• Conditions: Oral Health; Dental Trauma; Oral Health Knowledge, Attitude and Practice Among Patients; Mouth Protectors

• Registration Number: NCT06912451
• Lead Sponsor: Universidade Federal do Rio de Janeiro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2025-02-04
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-08-29
• Study Completion: 2025-12-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acceptability	Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use.	Acceptability will be assessed through a questionnaire on changes in the oral cavity associated with the use of the MG or in the MG itself. This questionnaire was developed by the authors of the study.
Incidence of soft tissue injuries	Before the MG is delivered, and at 1, 3, and 6 months after use	The following parameter will be evaluated: presence of mucosal injuries through clinical examinations
Periodontal and salivary parameters	Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.	The following parameters will be evaluated: visible plaque index, gingival bleeding index, salivary flow, salivary pH, buffering capacity, and salivary microorganism count.

Secondary Outcome Measures

Name	Time	Method
The perception of the body in sports practice (PeCoPes)	PeCoPes will be assessed before, 1, 3, and 6 months after MG use.	The perception of the body in sports practice (PeCoPes) will be assessed through a previously validated questionnaire.
The quality of life of athletes	Quality of life will be assessed before, 1, 3, and 6 months after MG use.	The quality of life will be assessed through some previously validated questionnaires.
The consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself.	Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.	The MG will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status.

Trial Locations

Locations (1)

Universidade Federal do Rio de Janeiro; 🇧🇷 Rio de Janeiro, RJ, Brazil