Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Trauma; Oral Health; Mouth Protectors; Oral Health Knowledge, Attitude and Practice Among Patients
• Intervention / Treatment: Device: Sport custom mouthguard

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana Pires da Costa, PhD Student; Phone Number: +552139382101; Email: maripires123@hotmail.com

Study Locations

• Brazil
  • RJ
    • Rio de Janeiro, RJ, Brazil, 21941-971
      • Recruiting
      • Universidade Federal do Rio de Janeiro
      • Contact: Mariana Pires da Costa, PhD Student; Phone Number: +552139382101; Email: maripires123@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sport Mouthguard; After the initial consultation for clinical examination data collection and anamnesis, an impression of the patient's upper dental arch will be made to create a custom mouthguard. This mouthguard will be made using two 3mm vinyl acetate ethylene sheets, following the recommendations for an appropriate mouthguard regarding trauma prevention and patient comfort.	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.; Other Names: Mouthguard; Mouth Protector

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	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.	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	The following parameter will be evaluated: presence of mucosal injuries through clinical examinations	Before the MG is delivered, and at 1, 3, and 6 months after use
Periodontal and salivary parameters	The following parameters will be evaluated: visible plaque index, gingival bleeding index, salivary flow, salivary pH, buffering capacity, and salivary microorganism count.	Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The perception of the body in sports practice (PeCoPes)	The perception of the body in sports practice (PeCoPes) will be assessed through a previously validated questionnaire.	PeCoPes will be assessed before, 1, 3, and 6 months after MG use.
The quality of life of athletes	The quality of life will be assessed through some previously validated questionnaires.	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.	The MG will be evaluated for bacterial contamination, delamination, roughness, dimensional changes related to shape and thickness, color change, and conservation status.	Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ); Conselho Nacional de Desenvolvimento Científico e Tecnólogico - CNPQ

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): August 29, 2025
• Study Completion (Estimated): December 26, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Questionnaire; Athletes; Oral health; Sports; Mouth Protectors; Dental Trauma
• Other Study ID Numbers: 75456123.9.0000.0268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The results will be released after the completion of the longitudinal study, which forms part of the responsible reseacher's PhD thesis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No