Actively Recruiting

Phase Not Applicable
Age: 7Years - 30Years
All Genders
Healthy Volunteers
NCT06912451

Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Led by Universidade Federal do Rio de Janeiro · Updated on 2025-04-04

136

Participants Needed

1

Research Sites

81 weeks

Total Duration

On this page

Sponsors

U

Universidade Federal do Rio de Janeiro

Lead Sponsor

C

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Sport Mouthguards: Devices for Preventing Dental Injuries in Sports

Who Can Participate

Age: 7Years - 30Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children, adolescents, and adults aged 7 to 30 years, with no systemic health issues, of both genders
  • Practice sports at least twice a week
Not Eligible

You will not qualify if you...

  • Have cavitated dental caries and/or periodontitis
  • Have Angle Class III malocclusion with negative anterior overjet
  • Have non-removable prostheses or accessories in upper or lower dental arches affecting mouthguard fitting
  • Use medications that may interfere with salivary parameters
  • Have neurological disorders or communication difficulties

AI-Screening

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Trial Site Locations

Total: 1 location

1

Universidade Federal do Rio de Janeiro

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

Actively Recruiting

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Research Team

M

Mariana Pires da Costa, PhD Student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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