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Evaluation of Individualized Mouthguards made of different materials and the Effect on the Preference and Wearability of athletes

The effect of different Ethylene-Vinyl Acetate (EVA) brands for applied for Custom-Fitted Mouthguards on the Preference and Wearability during sports practice: A randomized crossover clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9kkmchk
Enrollment
Unknown
Registered
2023-01-24
Start date
2022-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental injuries.

Interventions

A total of 30 athletes will be randomized in a controlled manner into 6 groups with 5 participants in each, whose athletes included in the study will be high-performance soccer players with permanent

Sponsors

Faculdade de Odontologia da Universidade Federal de Goiás
Lead Sponsor
Faculdade de Odontologia da Universidade Federal de Goiás
Collaborator

Eligibility

Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: To be a high-performance football athlete; To have a training routine of at least 5 days a week with a daily workload of 4 hours; To present good oral health, without the need for treatments; To have a minimum age of 16 years and be in permanent dentition with all teeth present (except third molars, which will be considered an exception in this criterion)

Exclusion criteria

Exclusion criteria: Not being under orthodontic treatment; Have missing teeth; Have a history of using mouthguards; Show inability to attend the 4 (four) meetings with the research team (for molding, delivery of individualized mouthguards and evaluations); Having difficulties using mouth guards in the stipulated period due to the competition calendar; Present subjective factors that make the use of mouthguards unfeasible

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the level of comfort during the use of individualized mouthguards made by three different brands of Ethylene-Vinyl Acetate (EVA), measured using a visual analogue scale filled in by the participant to measure 9 (nine) domains: comfort, volume, stability, hardness, breathing, speech, dry mouth sensation, retching and biting habit. Data will be collected after 5 (five) weeks of using each of the three mouthguards.

Secondary

MeasureTime frame
Measure and compare the degree of deformation of individualized mouthguards made by three different brands of Ethylene-Vinyl Acetate (EVA) as a function of the time of use, which will be measured in millimeters from the superposition of images obtained by scanning the protectors before being used. delivered to the participants and after 5 (five) weeks of use.;To evaluate and compare the degree of clinical adaptation of individualized mouthguards made of three different brands of Ethylene-Vinyl Acetate (EVA) as a function of the time of use, which will be analyzed through clinical evaluation of the parameters adaptation, retention and stability. Data will be collected in two moments: when each mouthguard is delivered to the participant and after 5 (five) weeks of use.;Evaluate and compare participants' willingness to pay (DAP) for individualized mouthguards made from three different brands of Ethylene-Vinyl Acetate (EVA), which will be measured in reais (R$) by the auction method. DAP data will be collected before the use of any mouthguard and after the use of each of the three protectors tested in the study, which will be made by different brands of Ethylene-Vinyl Acetate (EVA).;Evaluate and compare the preference of the participant after the use of individualized mouthguards made of three different brands of Ethylene-Vinyl Acetate (EVA), measured through a question in which the participant will indicate the preferred protector and will assign it up to 3 (three ) reasons for this choice among the aspects: comfort, volume, stability, hardness, breathing, speech, dry mouth sensation, retching and biting habit. Data will be collected after the period of use of the three mouthguards (after 15 weeks).

Countries

Brazil

Contacts

Public ContactLuiz Felipe Siqueira

Faculdade de Odontologia da Universidade Federal de Goiás

luizfelipe_r@discente.ufg.br+55 (62) 3209-6051

Outcome results

None listed

Source: REBEC (via WHO ICTRP)