Antimicrobial Agent for Reducing Bacteria in Aerosols and Oral Cavity
Condition: Dental Prophylaxis and Implant Surgery
Intervention: 0.2% w/v Chlorhexidine digluconate; Sodium fluoride toothpaste (Aquafresh Mild & Minty)
Intervention description: Participants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse.; Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily. They will then rinse their mouth thoroughly with water after brushing
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Listerine; Fluorides; Sodium Fluoride
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study will be to evaluate the effect of two week pre-surgical
      rinsing with an antimicrobial mouthrinse containing 0.2% w/v Chlorhexidine digluconate on the
      total number of plaque bacteria in the mouth 3 days post implant surgery. The study will be
      conducted at Eastman Clinical Investigation Centre (ECIC), University College London (UCL)
      Eastman Dental Institute. Participants will be those who require a single and simple surgical
      implant to be placed, and will be recruited from new patient referrals within the Eastman
      Dental Hospital
    

Eligibility criteria:

        Inclusion Criteria:

          -  Demonstrates understanding of the study and willingness to participate as evidenced by
             voluntary written informed consent and has received a signed and dated copy of the
             informed consent form.

          -  Aged between 18-64 years old.

          -  Understands and is willing, able and likely to comply with all study procedures and
             restrictions

          -  Good general and mental health with, in the opinion of the investigator or medically
             qualified designee:

               1. No clinically significant and relevant abnormalities in medical history or upon
                  oral examination.

               2. Absence of any condition that could affect the participant's safety or well being
                  or their ability to understand and follow study procedures and requirements.

          -  Females of childbearing potential who are, in the opinion of the investigator,
             practicing a reliable method of contraception

          -  Dental Health

               1. Good overall oral health in the opinion of investigator.

               2. A minimum of 20 permanent teeth.

               3. Requiring a single and simple implant (single tooth replacement with no bone
                  augmentation required for implant placement).

          -  Females of childbearing potential who are, in the opinion of the investigator,
             practising a reliable method of contraception.

        Exclusion Criteria:

          -  Women who are known to be pregnant or who are intending to become pregnant over the
             duration of the study

          -  Women who are breast-feeding

          -  Known or suspected intolerance or hypersensitivity to the study materials (or closely
             related compounds) or any of their stated ingredients

          -  Participation in another clinical study or receipt of an investigational drug within
             30 days of the screening visit

          -  Previous participation in this study

          -  Recent history (within the last 1 year) of alcohol or other substance abuse

          -  Use of antibiotics within 14 days prior to the Baseline visit or Implant surgery
             visit.

          -  An employee of the sponsor or the study site or members of their immediate family