Clinical trial NCT06912451: Sport Mouthguards: Devices for Preventing Dental Injuries in Sports
Official title: Sport Mouthguards: Devices for Preventing Dental and Alveolar Injuries in Sports - A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Health
Dental Trauma
Oral Health Knowledge, Attitude and Practice Among Patients
Mouth Protectors
Keywords: Mouth Protectors
Athletes
Sports
Dental Trauma
Questionnaire
Oral health
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnólogico - CNPQ
name: Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
First posted: 2025-04-04
Enrollment: 136
Sex: ALL
Minimum age (years): 7
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability
timeFrame: Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use.
measure: Incidence of soft tissue injuries
timeFrame: Before the MG is delivered, and at 1, 3, and 6 months after use
measure: Periodontal and salivary parameters
timeFrame: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.
Secondary outcomes:
measure: The perception of the body in sports practice (PeCoPes)
timeFrame: PeCoPes will be assessed before, 1, 3, and 6 months after MG use.
measure: The quality of life of athletes
timeFrame: Quality of life will be assessed before, 1, 3, and 6 months after MG use.
measure: The consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself.
timeFrame: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
state: RJ
Study officials:
References: