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Recruiting NCT06912451

Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

No phase Interventional Oral Health Dental Trauma Oral Health Knowledge, Attitude and Practice Among Patients Mouth Protectors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sport custom mouthguard.
Who it may be relevant to
Registry conditions: Oral Health, Dental Trauma, Oral Health Knowledge, Attitude and Practice Among Patients, Mouth Protectors. Basic parameters: 7 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Sport Mouthguards: Devices for Preventing Dental and Alveolar Injuries in Sports - A Longitudinal Study

Overview

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.

Interventions

  • Device Sport custom mouthguard
    This mouthguard will be made using two 3mm vinyl acetate ethylene sheets in a vacuum machine, following the recommendations for an appropriate mouthguard regarding trauma prevention and patient comfort. The patients will be monitored after 1, 3, and 6 months of using the mouthguard.

Primary outcome measures

  • Acceptability [Time frame: Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use.]
  • Incidence of soft tissue injuries [Time frame: Before the MG is delivered, and at 1, 3, and 6 months after use]
  • Periodontal and salivary parameters [Time frame: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.]
Secondary outcome measures (3)
  • The perception of the body in sports practice (PeCoPes) [Time frame: PeCoPes will be assessed before, 1, 3, and 6 months after MG use.]
  • The quality of life of athletes [Time frame: Quality of life will be assessed before, 1, 3, and 6 months after MG use.]
  • The consequences of use on the characteristics, state of conservation, and biological and physical properties of the MG itself. [Time frame: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Brazil · 1 center
  • Universidade Federal do Rio de Janeiro — Rio de Janeiro

Identifiers

NCT: NCT06912451 · 75456123.9.0000.0268

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗