Impact of Oral Hygiene Gels on Peri-implant Mucositis
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      Peri-implant mucositis is abnormal inflammation occurring around dental implants, increasing
      the risk of loss of bone support. The purpose of this study is to evaluate the impact of
      brushing the bacterial biofilm at the implant-mucosa interface with one of two,
      commercially-available dental gels over a 30-day period on amounts of biofilm and indices of
      mucosal inflammation. Adult subjects (> 19 years old) will be invited to consent if they have
      at least one dental implant displaying mucositis defined as Gingivitis Index of 2 or greater,
      no dental treatment in the previous 30 days, capable of normal toothbrushing, and no Sjogrens
      disease, immunodeficiency, pregnancy, poorly-controlled diabetes, or regular systemic
      antibiotics, anti-inflammatory drugs or immune suppressants. Ten patients in each tooth gel
      group will be instructed to apply a pea size amount of dentifrice brushing the implant and
      mucosa 2 times daily for 30 days. Baseline and 30-day examinations will be conducted to
      record Gingivitis Index, Plaque Index, probing depths, clinical photo, crevicular fluid, and
      adverse events.
    

Detailed description: 
      This will be a prospective, randomized, controlled, double-blind, single center study. Once
      eligibility has been determined, up to 21 Subjects will be enrolled. Subjects will be
      randomly assigned in a 1:1 ratio to treat with either Livionex Dental Gel (a plaque control
      gel that is safe for ingestion and is currently sold by Livionex Inc.) or the control
      Aquafresh toothpaste. Each study visit will last 30 minutes.

      The soft tissue around the dental implant will be observed at baseline and after 30 days for
      inflammation using the Gingivitis Index and probed with a UNC 15 periodontol probe for pocket
      depth and bleeding. A photograph will be taken of the most inflamed side of the implant.
      Plaque will be stained with oral hygiene staining rinse and evaluated for Plaque Index.
      Finally, a paper strip will be inserted between the gingiva and implant on facial and lingual
      sides for 30 seconds each.

      GINGIVITIS INDEX: Gingivitis score (GI)= Units on a scale 0 to 3 (0 = no inflammation, 1 =
      Mild inflammation slight change in color and little change in texture 2 = Moderate
      inflammation moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon
      probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous
      bleeding. GI scored=sum of GI scores divided by the number of sites (gingival gum line around
      the tooth) scored.

      PLAQUE INDEX Using Quigley Staining Hein Method with Turesky Modification:Units on a scale 0
      to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band
      of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two
      thirds of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth. Plaque
      score = sum of all scores divided by the number of sites (teeth) scored.

      Each patients will be instructed to brush around the implant with a pea size amount of
      dentifrice provided, twice daily for 30 days.
    

Intervention name(s): Livionex gel; Aquafresh gel
Intervention type(s): Other; Other
Intervention description(s): Brushing area of mucositis with gel; Aquafresh gel
Other intervention name(s): Aquafresh gel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, randomized, controlled, double-blind, single center
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment