Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

NCT06912451 | Recruiting DMC

• 1 other identifier: 75456123.9.0000.0268
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• The perception of the body in sports practice (PeCoPes)

  PeCoPes will be assessed before, 1, 3, and 6 months after MG use.

• The quality of life of athletes

  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.

  Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.

Study Arms (1)

Sport Mouthguard

EXPERIMENTAL

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

Interventions

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.

Also known as: Mouthguard, Mouth Protector

Sport Mouthguard

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ): collaborator

Study Sites (1)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-971, Brazil

RECRUITING

MeSH Terms

Conditions

Behavior

Interventions

Mouth Protectors

Intervention Hierarchy (Ancestors)

Preventive Dentistry; Dentistry; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Mariana Pires da Costa, PhD Student

CONTACT

+552139382101; maripires123@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: April 4, 2025
• Study Start: June 1, 2024
• Primary Completion: August 29, 2025
• Study Completion: December 26, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

BR (1)