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NCT Number: NCT06912451

Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

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.

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Key information

Age range

7 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio de Janeiro

Rio de Janeiro, 21941-971, Brazil

Location status: Recruiting

Location contact

Mariana Pires da Costa, PhD Student

CONTACT

[email protected]

+552139382101

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sport custom mouthguard

Device

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.

Other names: Mouthguard, Mouth Protector

Primary outcomes

  1. Acceptability

    Time frame: 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.

  2. Incidence of soft tissue injuries

    Time frame: 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

  3. Periodontal and salivary parameters

    Time frame: 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 outcomes

  1. 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 perception of the body in sports practice (PeCoPes) will be assessed through a previously validated questionnaire.

  2. The quality of life of athletes

    Time frame: 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.

  3. 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.

    The MG will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariana Pires da Costa, PhD Student

CONTACT

[email protected]

+552139382101

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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