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Effect of Hard Labial Reinforcement of a Mouthguard on the Degree of Satisfaction Among Rugby Players

Effect of Hard Labial Reinforcement of a Custom-made Mouthguard on the Degree of Satisfaction Among Rugby Players. A Randomized Crossover Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05238480
Enrollment
24
Registered
2022-02-14
Start date
2022-02-01
Completion date
2022-09-30
Last updated
2022-11-03

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

Conditions

Quality of Life, Satisfaction

Keywords

Mouthguard, Sports contat

Brief summary

This study assesses the effect of incorporating a hard labial layer to the front zone of a custom-made mouthguard on the degree of satisfaction of rugby players. Twenty-four rugby players will wear a custom-made Bioplast Xtreme conventional mouthguard (Bioplast Xtreme 4 × 125 + Bioplast 2 x 125; Scheu-Dental Company) and a custom-made Bioplast Xtreme Pro mouthguard (Bioplast Xtreme 4mm × 125 + Duran Layer 0.75mm; Bioplast 2mm x 125), two weeks per mouthguard. They will wear it during training sessions and competitions. The sequence will be randomized for one-half of the participants to start wearing the Bioplast Xtreme conventional and the other half the Bioplast Xtreme Pro mouthguard the first week. The participants will rate the degree of interference with oral functions or discomfort in reference to speeking, breathing, swallowing, gag reflex, tight or loose fitting, aesthetics and athletic performance, in a 10-point scale, considering 0 no discomfort/interference and 10 maximum discomfort/interference. After each session, players will also rate the perception of the protection, the degree of improvement on athletic performance and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.

Detailed description

This crossover intervention study aims to assess the effect of incorporating a hard labial layer to the front zone of a custom-made mouthguard on the degree of satisfaction of rugby players. Twenty-four rugby players will participate in this randomized crossover trial. Three hydrocolloid impressions will be made, two of their maxillary arches and one of their mandibular arches, and the casts will be poured immediately with Type IV dental stone. An interocclusal record will be obtained using an extra hard wax covering the tip of two wooden tongue depressors to assure a near centric relation and a minimum interocclusal distance of approximately 2 mm. Two different custom-made mouth guards will be made for each participant, a Bioplast Xtreme conventional mouthguard (Bioplast Xtreme 4 × 125 + Bioplast 2 x 125; Scheu-Dental Company) and a custom-made Bioplast Xtreme Pro mouthguard (Bioplast Xtreme 4mm × 125 + Duran Layer 0.75mm; Bioplast 2mm x 125). Conventional mouthguard will be fabricated using a pressure molding device and a 4-mm ethyl vinyl acetate foil made at 2 mm from the full depth of the labial sulcus, covering the second maxillary molar, and with the palatal margin extending 2 mm from the cervical line. To fabricate the occlusal adjustment a second 2-mm foil of ethyl vinyl acetate will be formed over the initial 4-mm layer. The maxillary and mandibular casts mounted to an articulator using the inter occlusal record will facilitate the accommodation of the occlusal surface to the antagonistic teeth. Bioplast Xtreme Pro will be made by the same procedure, except the incorporation of an extra layer of Duran between 4mm ethyl vinyl acetate foil and 2 mm ethyl vinyl acetate foil. The participants will be instructed to wear the mouth guards during training sessions and competitions. The sequence of use will be randomized to obtain one half of the participants wearing Xtreme Conventional mouthguard the first and the fourth week and the Xtreme Pro mouthguard the second and the third week. The other half will start wearing the first and the fourth week the Xtreme Pro mouthguard and the second and third week the Xtreme conventional mouthguard. The participants will evaluate using a 10-point scale the discomfort (gag reflex, tight or loose fitting), the level of interference with functions (speeking, breathing, swallowing, aesthetics and athletic performance), the protection, and the general satisfaction after each training session or match.

Interventions

DEVICEXC mouthguard

Use of a Xtreme Conventional custom-made mouthguard while playing rugby

DEVICEXP mouthguard

Use of a Xtreme Pro custom-made mouthguard while playing rugby

Sponsors

University of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Playing in Catalan/Spanish league of rugby for the season 2021-2022

Exclusion criteria

* Presence of dental caries * Players with periodontitis, * Players with temporomandibular joint pain * Players with active orthodontic treatment

Design outcomes

Primary

MeasureTime frameDescription
Degree of satisfaction using a questionnaireWeeks 1-4Participant satisfaction will be assessed by asking the question How satisfied are you with your mouthguard? using a 0-10 point scale, considering 0= totally dissatisfied and 10 = totally satisfied. Players rated the mouthguard just after each training session or after each match.

Secondary

MeasureTime frameDescription
Degree of interference on breathing using a questionnaireWeeks 1-4The degree of interference on breathing while using the mouthguard was assessed by asking the question How much do you think wearing the mouthguard interferes your ability to breath? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.
Degree of interference on swallowing using a questionnaireWeeks 1-4The degree of interference on swallowing while using the mouthguard will be assessed by asking the question How much do you think wearing the mouthguard interferes your ability to swallow? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.
Degree of discomfort regarding the gag reflex using a questionnaireWeeks 1-4The degree of discomfort regarding the gag reflex while using the mouthguard will be assessed by asking the question How much do you think wearing the mouthguard causes a gag reflex? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.
Degree of discomfort because the mouthguard fits too tight using a questionnaireWeeks 1-4The degree of discomfort because the mouthguard fits too tight will be assessed by asking the question How much do you think the mouthguard fits too tight? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.
Degree of interference on speech using a questionnaireWeeks 1-4The degree of interference on speech while using the mouthguard will be assessed by asking the question How much do you think wearing the mouthguard interferes your ability to speech? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.
Degree of interference on aesthetics using a questionnaireWeeks 1-4The degree of interference on aesthetics while using the mouthguard will be assessed by asking the question How much do you think wearing the mouthguard interferes on aesthetics? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.
Degree of interference on athletic performance using a questionnaireWeeks 1-4The degree of interference on athletic performance while using the mouthguard will be assessed by asking the question How much do you think wearing the mouthguard interferes athletic performance? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.
Degree of protection using a questionnaireWeeks 1-4The degree of protection perceived by the participant will be assessed by asking the question How much do you feel protected when you are wearing the mouthguard? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.
Cost-effectiveness analysis by assessing the degree of satisfaction and the cost of the mouthguardWeeks 1-4The time spent in the laboratory setting and the cost of the materials will be considered for the estimation of the cost-effectiveness of the mouthguard. Effectiveness will be considered as the degree of satisfaction with the mouthguard perceived by the participant.
Degree of discomfort related to the dislodgement of the mouthguard using a questionnaireWeeks 1-4The degree of discomfort because the mouthguard dislodges will be assessed by asking the question How much do you think the mouthguard fits too loose? using a 0-10 point scale (considering 0= anything to 10= very much). Players rated the mouthguard just after each training session or after each match.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026