Clinical trial NCT05238480: Effect of Hard Labial Reinforcement of a Mouthguard on the Degree of Satisfaction Among Rugby Players
Official title: Effect of Hard Labial Reinforcement of a Custom-made Mouthguard on the Degree of Satisfaction Among Rugby Players. A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction
Quality of Life
Keywords: Mouthguard
Sports contat
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of satisfaction using a questionnaire
timeFrame: Weeks 1-4
Secondary outcomes:
measure: Degree of interference on speech using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of interference on breathing using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of interference on swallowing using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of discomfort regarding the gag reflex using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of discomfort because the mouthguard fits too tight using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of discomfort related to the dislodgement of the mouthguard using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of interference on aesthetics using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of interference on athletic performance using a questionnaire
timeFrame: Weeks 1-4
measure: Degree of protection using a questionnaire
timeFrame: Weeks 1-4
measure: Cost-effectiveness analysis by assessing the degree of satisfaction and the cost of the mouthguard
timeFrame: Weeks 1-4
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Jordi Martinez-Gomis
state: Catalonia
Study officials:
affiliation: University of Barcelona
name: Jordi Martinez-Gomis, DDS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Jordi Martinez-Gomis, DDS PhD
role: STUDY_CHAIR
References:
citation: Zamora-Olave C, Willaert E, Montero-Blesa A, Riera-Punet N, Martinez-Gomis J. Risk of orofacial injuries and mouthguard use in water polo players. Dent Traumatol. 2018 Dec;34(6):406-412. doi: 10.1111/edt.12434. Epub 2018 Oct 10.
citation: Gomez-Gimeno A, Zamora-Olave C, Cordobes-Navarro M, Willaert E, Martinez-Gomis J. Satisfaction with shortening the palatal extension of a mouthguard for water polo players: A randomized crossover study. Dent Traumatol. 2019 Apr;35(2):135-141. doi: 10.1111/edt.12455. Epub 2019 Jan 7.
citation: Zamora-Olave C, Willaert E, Parera L, Riera-Punet N, Martinez-Gomis J. Experience with mouthguards and prevalence of orofacial injuries among field hockey players in Catalonia. Dent Traumatol. 2020 Jun;36(3):285-290. doi: 10.1111/edt.12531. Epub 2019 Dec 16.
citation: Flores-Figueiras C, Zamora-Olave C, Willaert E, Martinez-Gomis J. Effect of thickness and occlusal accommodation on the degree of satisfaction with mouthguard use among water polo players: A randomized crossover trial. Dent Traumatol. 2020 Dec;36(6):670-679. doi: 10.1111/edt.12583. Epub 2020 Jul 20.
citation: Iglesias-Porqueras N, Zamora-Olave C, Willaert E, Martinez-Gomis J. Attitudes and opinions towards the prevention of orofacial injuries among water polo coaches in Catalonia: A cross-sectional study. Dent Traumatol. 2021 Aug;37(4):623-630. doi: 10.1111/edt.12675. Epub 2021 Mar 27.
citation: Bochnig MS, Oh MJ, Nagel T, Ziegler F, Jost-Brinkmann PG. Comparison of the shock absorption capacities of different mouthguards. Dent Traumatol. 2017 Jun;33(3):205-213. doi: 10.1111/edt.12324. Epub 2017 Mar 14.
citation: Sarac R, Helbig J, Drager J, Jost-Brinkmann PG. A Comparative Study of Shock Absorption Capacities of Custom Fabricated Mouthguards using a Triangulation Sensor. Materials (Basel). 2019 Oct 28;12(21):3535. doi: 10.3390/ma12213535.