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

NCT03845621 | Completed

• 1 other identifier: HOUB2018/031
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Degree of satisfaction using a questionnaire

  Participant 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.

  Weeks 1-4

Secondary Outcomes (11)

• Degree of interference on speech using a questionnaire

  Weeks 1-4

• Degree of interference on breathing using a questionnaire

  Weeks 1-4

• Degree of interference on swallowing using a questionnaire

  Weeks 1-4

• Degree of discomfort regarding the gag reflex using a questionnaire

  Weeks 1-4

• Degree of discomfort because the mouthguard fits too tight using a questionnaire

  Weeks 1-4

Study Arms (2)

CM-OA-OA-CM Sequence

ACTIVE COMPARATOR

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.

Device: Conventional Mouthguard; Device: Occlusal-adjusted Mouthguard

OA-CM-CM-OA Sequence

ACTIVE COMPARATOR

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.

Device: Conventional Mouthguard; Device: Occlusal-adjusted Mouthguard

Interventions

Conventional Mouthguard DEVICE

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

CM-OA-OA-CM Sequence; OA-CM-CM-OA Sequence

Occlusal-adjusted Mouthguard DEVICE

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

CM-OA-OA-CM Sequence; OA-CM-CM-OA Sequence

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Players with dental caries, periodontitis or temporomandibular joint pain

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Jordi Martinez-Gomis

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (4)

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

  PMID: 19408816 BACKGROUND

• 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.

  PMID: 30156365 BACKGROUND

• 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.

  PMID: 30481393 BACKGROUND

• 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.

  PMID: 32590885 RESULT

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor DDS. PhD

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 19, 2019
• Study Start: February 21, 2019
• Primary Completion: June 1, 2019
• Study Completion: July 10, 2019
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

ES (1)