Effect of Shortening the Palatal Extension of the Mouthguard on the Degree of Satisfaction of Water Polo Players

NCT03685318 | Completed

• 1 other identifier: HOUB2018/004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study assessed the influence of a reduction of the palate extension of a custom-made mouthguard on the degree of satisfaction of elite water polo players. Eighteen water polo players wore a custom-made conventional mouthguard or a reduced palate extension mouthguard during the training sessions and for competing for two weeks. The sequence was randomized to obtain one-half of the participants started the first week wearing the conventional mouthguard, and the other half wearing the shortened mouthguard. The participants rated the degree of discomfort in reference to speech, breathing, swallowing, nauseas/vomiting, pressure/pain, loosening, aesthetics, and athletic performance, in a 10-point scale, considering 0 no discomfort and 10 maximum discomfort. After each session, players also rated the perception of protection and the degree of satisfaction in a 10-point scale, considering 0 no protection/satisfaction and 10 maximum protection/satisfaction.

Conditions

Mouth Protectors; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Degree of satisfaction with the mouthguard

  Participant satisfaction was 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 (9)

• Degree of interference on speech while using the mouthguard

  Weeks 1-4

• Degree of interference on breathing while using the mouthguard

  Weeks 1-4

• Degree of interference on swallowing while using the mouthguard

  Weeks 1-4

• Degree of discomfort regarding the gag reflex while using the mouthguard

  Weeks 1-4

• Degree of discomfort because the mouthguard fits too tight

  Weeks 1-4

Study Arms (2)

Conventional mouthguard

ACTIVE COMPARATOR

Use of a conventional custom-made mouthguard while playing water polo for two weeks. The conventional mouthguard is designed with the palatal margin at 6 mm from the cervical line.

Device: Use of conventional mouthguard

Shortened mouthguard

ACTIVE COMPARATOR

Use of a shortened custom-made mouthguard while playing water polo for two weeks. The shortened mouthguard is designed with the palatal margin at 2 mm from the cervical line.

Device: Use of shortened mouthguard

Interventions

Use of conventional mouthguard DEVICE

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

Conventional mouthguard

Use of shortened mouthguard DEVICE

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

Shortened mouthguard

Eligibility Criteria

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

You may qualify if:

• water polo players playing in maximum Spanish category for the season 2017-2018
• Obtaining written informed consent for participating in the project (model consent form)

You may not qualify if:

• Players with dental caries, with periodontitis or with 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 (6)

• 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

• Gebauer DP, Williamson RA, Wallman KE, Dawson BT. The effect of mouthguard design on respiratory function in athletes. Clin J Sport Med. 2011 Mar;21(2):95-100. doi: 10.1097/JSM.0b013e31820428b0.

  PMID: 21358498 BACKGROUND

• Maeda Y, Machi H, Tsugawa T. Influences of palatal side design and finishing on the wearability and retention of mouthguards. Br J Sports Med. 2006 Dec;40(12):1006-8. doi: 10.1136/bjsm.2006.030874. Epub 2006 Sep 25.

  PMID: 17000712 BACKGROUND

• Lloyd JD, Nakamura WS, Maeda Y, Takeda T, Leesungbok R, Lazarchik D, Dorney B, Gonda T, Nakajima K, Yasui T, Iwata Y, Suzuki H, Tsukimura N, Churei H, Kwon KR, Choy MMH, Rock JB. Mouthguards and their use in sports: Report of the 1st International Sports Dentistry Workshop, 2016. Dent Traumatol. 2017 Dec;33(6):421-426. doi: 10.1111/edt.12375.

  PMID: 28965361 BACKGROUND

• Parker K, Marlow B, Patel N, Gill DS. A review of mouthguards: effectiveness, types, characteristics and indications for use. Br Dent J. 2017 Apr 21;222(8):629-633. doi: 10.1038/sj.bdj.2017.365.

  PMID: 28428580 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 RESULT

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: September 10, 2018
• First Posted: September 26, 2018
• Study Start: March 1, 2018
• Primary Completion: May 15, 2018
• Study Completion: June 15, 2018
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

ES (1)