Oral HealthNCT06912451
Sport Mouthguards: Devices for Preventing Dental Injuries in Sports
A study testing Sport custom mouthguard in people with Oral Health and Dental Trauma, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health, Dental Trauma, Oral Health Knowledge, Attitude and Practice Among Patients
- What is being tested?
- Sport custom mouthguard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2024to 26 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-971
Mariana Pires da Costa, PhD Student, +552139382101, maripires123@hotmail.com
About this study
Official title: 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.
- Conditions
- Oral Health, Dental Trauma, Oral Health Knowledge, Attitude and Practice Among Patients, Mouth Protectors
- Being tested
- Sport custom mouthguard
- Keywords
- Mouth Protectors, Athletes, Sports, Dental Trauma, Questionnaire, Oral health
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sport custom mouthguardDevice
Also called Mouthguard, Mouth Protector
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sport custom mouthguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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)
The perception of the body in sports practice (PeCoPes) will be assessed through a previously validated questionnaire.
Measured: 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.
Measured: 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.
Measured: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Jun 2024
- Primary completion29 Aug 2025 (estimated)
- Study completion26 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
- Responsible party
- Principal investigator, Mariana Pires da Costa, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912451
- Sponsor's protocol ID
- 75456123.9.0000.0268
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The results will be released after the completion of the longitudinal study, which forms part of the responsible reseacher's PhD thesis.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sport Mouthguards: Devices for Preventing Dental and Alveolar Injuries in Sports - A Longitudinal Study
- ClinicalTrials.gov ID
- NCT06912451
- Acronym / sponsor ID
- 75456123.9.0000.0268
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 26 Dec 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sport Mouthguard | Experimental | Device: Sport custom mouthguardAfter 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. |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sport custom mouthguardAlso: Mouthguard, Mouth ProtectorThis 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. | Device | Sport Mouthguard |
Primary outcome
Acceptability
Time frame: Acceptability 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.
Incidence of soft tissue injuries
Time frame: Before the MG is delivered, and at 1, 3, and 6 months after use
The following parameter will be evaluated: presence of mucosal injuries through clinical examinations
Periodontal and salivary parameters
Time frame: Before 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.
3 secondary outcomes
The perception of the body in sports practice (PeCoPes)
Time frame: PeCoPes will be assessed before, 1, 3, and 6 months after MG use.
The quality of life of athletes
Time frame: 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.
Time frame: Before the MG is delivered, immediately after installation, and at 1, 3, and 6 months after use.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: Undecided. The results will be released after the completion of the longitudinal study, which forms part of the responsible reseacher's PhD thesis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sport custom mouthguard in people with Oral Health and Dental Trauma, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Pires da Costa, PhD Student (+552139382101, maripires123@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Acceptability will be evaluated before the MG is delivered, immediately after delivery, and at 1, 3, and 6 months after use.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.