Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

NCT ID: NCT06912451

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-12-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sport custom mouthguard

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Mouthguard; Mouth Protector

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)

UNKNOWN

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Mariana Pires da Costa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Mariana Pires da Costa, PhD Student

Role: CONTACT

maripires123@hotmail.com

+552139382101

Facility Contacts

Mariana Pires da Costa, PhD Student

Role: primary

maripires123@hotmail.com

+552139382101

Other Identifiers

75456123.9.0000.0268

Identifier Type: -

Identifier Source: org_study_id