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

NCT ID: NCT05238480

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-09-30

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.

Conditions

Satisfaction; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

XC-XP-XP-XC Sequence

Use of the Xtreme Conventional mouthguard (XC) while playing rugby for first and fourth weeks and the Xtreme Pro mouthguard (XP) for the second and third weeks.

Group Type: ACTIVE_COMPARATOR

XC mouthguard

Intervention Type: DEVICE

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

XP mouthguard

Intervention Type: DEVICE

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

XP-XC-XC-XP Sequence

Use of the Xtreme Pro mouthguard (XP) while playing rugby for first and fourth weeks and the Xtreme Conventional mouthguard (XC) for the second and third weeks.

Group Type: ACTIVE_COMPARATOR

XC mouthguard

Intervention Type: DEVICE

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

XP mouthguard

Intervention Type: DEVICE

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

Interventions

XC mouthguard

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

Intervention Type: DEVICE

XP mouthguard

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Jordi Martinez-Gomis

Associate Professor, Serra Hunter Fellow, Department of Prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordi Martinez-Gomis, DDS PhD

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Jordi Martinez-Gomis, DDS PhD

Role: STUDY_CHAIR

University of Barcelona

Locations

Jordi Martinez-Gomis

L'Hospitalet de Llobregat, Catalonia, Spain

Countries

Spain

References

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Reference Type: BACKGROUND

PMID: 30156365 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30481393 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31765062 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 32590885 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 28231638 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31661939 (View on PubMed)

Other Identifiers

HOUB2021/057

Identifier Type: -

Identifier Source: org_study_id