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Comfort and usability of customized mouthguards obtained by conventional molding and through an intraoral scanner and 3D printers: randomized clinical trial

Comfort and usability of personalized mouthguards obtained by conventional and digital flow impressions: a randomized, parallel-arm clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-3gj96xw
Enrollment
Unknown
Registered
2025-03-17
Start date
2024-06-01
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

Mouth Protectors

Interventions

This is a randomized, parallel-arm, double-blind clinical study. Experimental unit: 40 amateur athletes using customized mouthguards and working models for making 80 mouthguards. Study factor: protoco
and 2. Experimental group, making of 40 mouthguards, through digital scanning of the upper and lower arches, making of models printed in three-dimensional (3D) resin, making of protectors with thermop
accuracy of the models obtained by the 2 molding protocols
adaptation and thickness of the protector
time of the steps of making the mouthguard
patient satisfaction regarding the use of the protector. Experimental methods: A) visual analog scale with 5 questions - patient satisfaction regarding the molding protocol
B) computed tomography, digital caliper, weighing of the protectors with silicone in the internal portion - adaptation and thickness of the protector
C) measurement with digital caliper - accuracy of the models
D) visual analog scale with 12 questions - patient satisfaction with the use of mouthguards. Data analysis method: The data will be analyzed by statistical tests that adapt to the data profile. The st
J01.637.708.560

Sponsors

Faculdade de Odontologia Universidade Federal de Uberlândia
Lead Sponsor
Hospital Odontológico da Universidade Federal de Uberlândia
Collaborator

Eligibility

Age
16 Years to No maximum

Inclusion criteria

Inclusion criteria: Young and adult athletes of both genders; over 16 years of age; with sufficient critical ability to answer the questionnaire objectively; who regularly practice some sport at least twice a week and who agree to use a mouthguard in all sports activities; patient who has a medical history that does not compromise the evolution of results; who has the habit of brushing their teeth at least twice a day; who has posterior occlusal stability and who has a normal periodontal condition according to probing parameters

Exclusion criteria

Exclusion criteria: Athletes of both genders; who have recently suffered a dentoalveolar trauma and are in pain; who have a recent root, alveolar or condylar fracture; who need dental retention; who have some chronic disease with oral manifestations; who have some oral pathology considered serious; patients with very poor oral hygiene; patients with occlusal instability; patients with advanced periodontal disease; patients with allergies to any material that will be used at work

Design outcomes

Primary

MeasureTime frame
Primary outcome – It is expected to find a good adaptation of the mouthguard made by digital flow, which is similar or superior to the conventional control mouthguard, evaluating their adaptation in the mouths of patients with light silicone, and weighing the protectors with and without silicone in the internal portion to compare the differences in weighing

Secondary

MeasureTime frame
Secondary outcome – It is expected to observe greater comfort and usability of mouthguards made by digital flow, compared to conventional control protectors, evaluating the comfort and fit of the protectors using a 10 cm Visual Analog Scale, marking numbers from 0 to 10 at the end of each evaluation. The Visual Analog Scale will be applied to the patient to subjectively evaluate 12 criteria regarding the use of the protector in 4 moments – immediately, after 7 days, 30 and 90 days of use

Countries

Brazil

Contacts

Public ContactCarlos Soares

Universidad Federal de Uberlandia

carlosjsoares@ufu.br+55 (34) 3225-8119

Outcome results

None listed

Source: REBEC (via WHO ICTRP)