NCT05238480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

February 3, 2022

Last Update Submit

November 2, 2022

Conditions

SatisfactionQuality of Life

Keywords

MouthguardSports contat

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 (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

XC-XP-XP-XC Sequence

ACTIVE COMPARATOR

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.

Device: XC mouthguardDevice: XP mouthguard

XP-XC-XC-XP Sequence

ACTIVE COMPARATOR

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.

Device: XC mouthguardDevice: XP mouthguard

Interventions

XC mouthguardDEVICE

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

XC-XP-XP-XC SequenceXP-XC-XC-XP Sequence
XP mouthguardDEVICE

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

XC-XP-XP-XC SequenceXP-XC-XC-XP Sequence

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Playing in Catalan/Spanish league of rugby for the season 2021-2022

You may not qualify if:

  • Presence of dental caries
  • Players with periodontitis,
  • Players with temporomandibular joint pain
  • Players with active orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordi Martinez-Gomis

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Related Publications (7)

  • 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: 30156365BACKGROUND

  • 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: 30481393BACKGROUND

  • 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.

    PMID: 31765062BACKGROUND

  • 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: 32590885BACKGROUND

  • 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.

    PMID: 33774914BACKGROUND

  • 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.

    PMID: 28231638BACKGROUND

  • 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.

    PMID: 31661939BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jordi Martinez-Gomis, DDS PhD

    University of Barcelona

    PRINCIPAL INVESTIGATOR

  • Jordi Martinez-Gomis, DDS PhD

    University of Barcelona

    STUDY CHAIR

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, Serra Hunter Fellow, Department of Prosthodontics

Study Record Dates

First Submitted

February 3, 2022

First Posted

February 14, 2022

Study Start

February 1, 2022

Primary Completion

May 31, 2022

Study Completion

September 30, 2022

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

ES(1)