Next Science Antimicrobial Mouth Rinse Study
Condition: Gingivitis; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention
      of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial
      flora and measuring gingival inflammation and bleeding.
    

Detailed description: 
      Baseline, Visit 1:

      Prior to this visit subjects will be asked not to perform any oral hygiene the morning of the
      visit. They will also be asked not to use medicated lozenges, breath mints, toothpicks, eat,
      drink (except water), smoke and/or chew gum the morning of the study visit. Subjects will be
      asked to read and sign an informed consent and they will be given a signed copy. Personal
      medical history information will be reviewed and retained as site source documentation.
      Demographic Information and entrance criteria will be assessed. A comprehensive oral
      examination will then be conducted to evaluate the oral and perioral region, including hard
      and soft tissues. This will include periodontal charting for pocket depths, plaque scores as
      well as gingival index and bleeding scores. Plaque samples will be collected from the
      following four sites- mesial surface of maxillary first molar on left side, distal surface of
      maxillary first premolar on right side, mesial surface of mandibular second molar on left
      side and distal surface of mandibular lateral incisor on right side. If any of these four
      teeth are missing, the next tooth mesial to it will be used to collect the plaque sample.

      Visit 2: Dental Prophylaxis, Oral Hygiene Instruction and Product Dispensation Subjects will
      receive a whole-mouth dental prophylaxis by the dental hygienist. For logistical reasons, the
      Dental Prophylaxis visit may occur within 2 weeks of the Baseline Visit. This visit will also
      include instructions on oral hygiene, dispensation of tooth brush/toothpaste and the oral
      rinse product. The experimental oral rinse product and the placebo will be provided by the
      manufacturer fully coded in prepacked bottles with the code numbers. Subjects will be
      instructed to brush their teeth and rinse their mouth with the dispensed product twice daily
      (AM/PM) for 30 seconds. A sheet of paper with pre-marked dates will be provided to each
      subject for them to record the time of the day they rinsed and duration. Subjects will be
      asked not to perform any oral hygiene the morning of their next visit. They will also be
      asked not to use medicated lozenges, breath mints, toothpicks, eat, drink (except water),
      smoke and/or chew gum the morning of the next study visit.

      Week 6, Visit 3:

      Subjects will be asked if they have performed any oral hygiene the morning of the visit. They
      will also be asked if they have used medicated lozenges, breath mints, toothpicks, eaten, had
      anything to drink (other than water), smoked and/or chewed gum the morning of the study
      visit. The paper sheet with recording of their rinsing habits will be collected. An oral
      examination will be conducted, an assessment of plaques and gingival scores will occur with
      periodontal charting for pocket depths, plaque scores as well as gingival index and bleeding
      scores. Dental plaque samples will be collected as before from the same sites. Any untoward
      experiences and findings will be recorded (example- change in taste sensation, any ulcers,
      blisters, etc.). New paper sheet to document their daily use of oral rinse will be provided.
      Subjects will be asked not to perform any oral hygiene the morning of their next visit. They
      will also be asked not to use medicated lozenges, breath mints, toothpicks, eat, drink
      (except water), smoke and/or chew gum the morning of the next study visit.

      Week 12, Visit 4:

      Subjects will be asked if they have performed any oral hygiene the morning of the visit. They
      will also be asked if they have used medicated lozenges, breath mints, toothpicks, eaten, had
      anything to drink (other than water), smoked and/or chewed gum the morning of the study
      visit.

      The paper sheet with recording of their rinsing habits will be collected. Full mouth
      periodontal charting to include plaque and bleeding scores as well as gingival index will be
      recorded and dental plaque samples collected as before (from the same sites). Any untoward
      experiences and findings will be recorded (example- change in taste sensation, any ulcers,
      blisters, etc.). Patients will be informed of any dental treatment needs and general comments
      and Adverse Events, if applicable, will be recorded. A subject accountability form will be
      completed and subjects will be dismissed from the study. A subject accountability form will
      also be completed for subjects who drop out of the study prior to its completion.
    

Intervention name(s): Next Science OTC Oral Rinse with Essential Oils; OTC Oral Rinse Control
Intervention type(s): Combination Product; Combination Product
Intervention description(s): This group will receive Next Science Oral Rinse with Essential Oils and the other half will be give OTC Oral Rinse Control; This group will receive OTC Oral Rinse Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One half of subjects will be given test product other half will be given placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Gingival Index; Plaque Index; Bleeding; Pocket Depth