Effect of Occlusal Accommodation of the Mouthguard on the Degree of Satisfaction of Water Polo Players

NCT ID: NCT03845621

Last Updated: 2022-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-21
• Study Completion Date: 2019-07-10

Brief Summary

This study assesses the effect of adjusting the occlusal surface of a custom-made mouthguard on the degree of satisfaction with a mouthguard among water polo players. Twenty-four water polo players will wear a custom-made conventional mouthguard and a custom-made mouthguard with occlusal adjustment, two weeks per mouthguard. They will wear it during training sessions and for competing. The sequence will be randomized to obtain one-half of the participants starting the first week wearing the conventional mouthguard, and the other half wearing the mouthguard with occlusal adjustment. The participants will rate the degree of interference with oral functions or discomfort in reference to speech, breathing, swallowing, gag reflex, fits too tight, fits too loose, aesthetics and athletic performance, in a 10-point scale, considering 0 no discomfort/interference and 10 maximum discomfort/interference. After each session, players also rated the perception of 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 adjusting the occlusal surface of a custom-made mouthguard on the degree of satisfaction with a mouthguard among water polo players. Twenty-four water polo players will participate in this randomized crossover trial. Two different custom-made mouth guards will be made for each participant, a conventional one and an occlusal-adjusted mouthguard. Both types of mouthguard will be fabricated using a pressure molding device and 4-mm ethyl vinyl acetate foils. The conventional mouth guards will be 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 adjusted mouthguard 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 an inter occlusal record will facilitate the accommodation of the occlusal surface to the antagonistic teeth. 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 beginning the first and the fourth week wearing the conventional mouthguard and the second and the third wearing the occlusal-adjusted mouthguard. The other half will start wearing the first and the fourth week the mouthguard with occlusal-adjusted mouthguard and the second and third week wearing the conventional mouthguard. The participants will evaluate on a 10-point scale for discomfort (gag reflex, fits too tight, fits too loose), interference with functions (speech, breathing, swallowing, aesthetics, and athletic performance), protection, and 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

CM-OA-OA-CM Sequence

Use of a conventional custom-made mouthguard (CM) while playing water polo for first and fourth weeks and the occlusal-adjusted custom-made mouthguard (OA) for the second and third weeks.

Group Type: ACTIVE_COMPARATOR

Conventional Mouthguard

Intervention Type: DEVICE

Use of a conventional custom-made mouthguard while playing water polo

Occlusal-adjusted Mouthguard

Intervention Type: DEVICE

Use of an occlusal-adjusted custom-made mouthguard while playing water polo

OA-CM-CM-OA Sequence

Use of an occlusal-adjusted custom-made mouthguard (OA) for the first and fourth weeks and a conventional custom-made mouthguard (CM) while playing water polo for the second and third weeks.

Group Type: ACTIVE_COMPARATOR

Conventional Mouthguard

Intervention Type: DEVICE

Use of a conventional custom-made mouthguard while playing water polo

Occlusal-adjusted Mouthguard

Intervention Type: DEVICE

Use of an occlusal-adjusted custom-made mouthguard while playing water polo

Interventions

Conventional Mouthguard

Use of a conventional custom-made mouthguard while playing water polo

Intervention Type: DEVICE

Occlusal-adjusted Mouthguard

Use of an occlusal-adjusted custom-made mouthguard while playing water polo

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Playing in the highest Spanish league of water polo for the season 2018- 2019

Exclusion Criteria

• Players with dental caries, periodontitis or temporomandibular joint pain

• 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 DDS. PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jordi Martinez-Gomis

L'Hospitalet de Llobregat, Barcelona, Spain

Countries

Spain

References

Geary JL, Clifford TJ, Kinirons MJ. Occlusal accommodation and mouthguards for prevention of orofacial trauma. Oral Health Prev Dent. 2009;7(1):55-9.

Reference Type: BACKGROUND

PMID: 19408816 (View on PubMed)

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.

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)

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.

Reference Type: RESULT

PMID: 32590885 (View on PubMed)

Other Identifiers

HOUB2018/031

Identifier Type: -

Identifier Source: org_study_id