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Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06912451
Enrollment
136
Registered
2025-04-04
Start date
2024-06-01
Completion date
2025-12-26
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Trauma, Mouth Protectors, Oral Health, Oral Health Knowledge, Attitude and Practice Among Patients

Keywords

Mouth Protectors, Athletes, Sports, Dental Trauma, Questionnaire, Oral health

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.

Interventions

DEVICESport 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.

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
CollaboratorUNKNOWN
Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of soft tissue injuriesBefore the MG is delivered, and at 1, 3, and 6 months after useThe following parameter will be evaluated: presence of mucosal injuries through clinical examinations
AcceptabilityAcceptability 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.
Periodontal and salivary parametersBefore 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

MeasureTime frameDescription
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 athletesQuality 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.

Countries

Brazil

Contacts

Primary ContactMariana Pires da Costa, PhD Student
maripires123@hotmail.com+552139382101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026