Effect of Hard Labial Reinforcement of a Mouthguard on the Degree of Satisfaction Among Rugby Players
Condition: Satisfaction; Quality of Life
Study type: Interventional

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.
    

Detailed description: 
      This crossover intervention study aims to assess 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 participate in this randomized crossover trial. Three
      hydrocolloid impressions will be made, two of their maxillary arches and one of their
      mandibular arches, and the casts will be poured immediately with Type IV dental stone. An
      interocclusal record will be obtained using an extra hard wax covering the tip of two wooden
      tongue depressors to assure a near centric relation and a minimum interocclusal distance of
      approximately 2 mm. Two different custom-made mouth guards will be made for each participant,
      a 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). Conventional mouthguard will be fabricated
      using a pressure molding device and a 4-mm ethyl vinyl acetate foil 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 adjustment 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 the inter occlusal record will
      facilitate the accommodation of the occlusal surface to the antagonistic teeth. Bioplast
      Xtreme Pro will be made by the same procedure, except the incorporation of an extra layer of
      Duran between 4mm ethyl vinyl acetate foil and 2 mm ethyl vinyl acetate foil. 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
      wearing Xtreme Conventional mouthguard the first and the fourth week and the Xtreme Pro
      mouthguard the second and the third week. The other half will start wearing the first and the
      fourth week the Xtreme Pro mouthguard and the second and third week the Xtreme conventional
      mouthguard. The participants will evaluate using a 10-point scale the discomfort (gag reflex,
      tight or loose fitting), the level of interference with functions (speeking, breathing,
      swallowing, aesthetics and athletic performance), the protection, and the general
      satisfaction after each training session or match.
    

Intervention name(s): XC mouthguard; XP mouthguard
Intervention type(s): Device; Device
Intervention description(s): Use of a Xtreme Conventional custom-made mouthguard while playing rugby; Use of a Xtreme Pro custom-made mouthguard while playing rugby
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mouthguard; Sports contat