- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05238480
Effect of Hard Labial Reinforcement of a Mouthguard on the Degree of Satisfaction Among Rugby Players
Effect of Hard Labial Reinforcement of a Custom-made Mouthguard on the Degree of Satisfaction Among Rugby Players. A Randomized Crossover Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Catalonia
-
L'Hospitalet De Llobregat, Catalonia, Spain, 08907
- Jordi Martinez-Gomis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Use of a Xtreme Conventional custom-made mouthguard while playing rugby
Use of a Xtreme Pro custom-made mouthguard while playing rugby
|
Active Comparator: 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.
|
Use of a Xtreme Conventional custom-made mouthguard while playing rugby
Use of a Xtreme Pro custom-made mouthguard while playing rugby
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of satisfaction using a questionnaire
Time Frame: Weeks 1-4
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of interference on speech using a questionnaire
Time Frame: Weeks 1-4
|
The degree of interference on speech while using the mouthguard will be assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to speech?" using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Degree of interference on breathing using a questionnaire
Time Frame: Weeks 1-4
|
The degree of interference on breathing while using the mouthguard was assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to breath?" using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Degree of interference on swallowing using a questionnaire
Time Frame: Weeks 1-4
|
The degree of interference on swallowing while using the mouthguard will be assessed by asking the question "How much do you think wearing the mouthguard interferes your ability to swallow?" using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Degree of discomfort regarding the gag reflex using a questionnaire
Time Frame: Weeks 1-4
|
The degree of discomfort regarding the gag reflex while using the mouthguard will be assessed by asking the question "How much do you think wearing the mouthguard causes a gag reflex?" using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Degree of discomfort because the mouthguard fits too tight using a questionnaire
Time Frame: Weeks 1-4
|
The degree of discomfort because the mouthguard fits too tight will be assessed by asking the question "How much do you think the mouthguard fits too tight?"
using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Degree of discomfort related to the dislodgement of the mouthguard using a questionnaire
Time Frame: Weeks 1-4
|
The degree of discomfort because the mouthguard dislodges will be assessed by asking the question "How much do you think the mouthguard fits too loose?"
using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Degree of interference on aesthetics using a questionnaire
Time Frame: Weeks 1-4
|
The degree of interference on aesthetics while using the mouthguard will be assessed by asking the question "How much do you think wearing the mouthguard interferes on aesthetics?" using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Degree of interference on athletic performance using a questionnaire
Time Frame: Weeks 1-4
|
The degree of interference on athletic performance while using the mouthguard will be assessed by asking the question "How much do you think wearing the mouthguard interferes athletic performance?"
using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Degree of protection using a questionnaire
Time Frame: Weeks 1-4
|
The degree of protection perceived by the participant will be assessed by asking the question "How much do you feel protected when you are wearing the mouthguard?" using a 0-10 point scale (considering 0= anything to 10= very much).
Players rated the mouthguard just after each training session or after each match.
|
Weeks 1-4
|
Cost-effectiveness analysis by assessing the degree of satisfaction and the cost of the mouthguard
Time Frame: Weeks 1-4
|
The time spent in the laboratory setting and the cost of the materials will be considered for the estimation of the cost-effectiveness of the mouthguard.
Effectiveness will be considered as the degree of satisfaction with the mouthguard perceived by the participant.
|
Weeks 1-4
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jordi Martinez-Gomis, DDS PhD, University of Barcelona
- Study Chair: Jordi Martinez-Gomis, DDS PhD, University of Barcelona
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HOUB2021/057
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Children's National Research InstituteCompletedProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
Clinical Trials on XC mouthguard
-
University Ramon LlullCompletedMouth Breathing
-
Amy LiewCompleted
-
Royal Surrey County Hospital NHS Foundation TrustKing's College LondonCompleted
-
University of FloridaCompletedBurning Mouth Syndrome | Burning MouthUnited States
-
University of BarcelonaCompletedQuality of Life | Mouth ProtectorsSpain
-
New York Institute of TechnologyCompleted
-
Khon Kaen UniversityCompletedDentine Hypersensitivity | Tooth ErosionThailand
-
Kenneth BeerAllerganUnknownMandibular HypoplasiaUnited States
-
University of OklahomaACE Surgical Supply, Inc.CompletedOral Ridge PreservationUnited States
-
Össur EhfMethodist Rehabilitation Center; Baker Orthotics & Prosthetics; Virginia Prosthetics...CompletedAmputation | Prosthesis UserUnited States