Next Science Antimicrobial Mouth Rinse Study

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.

Inclusion Criteria:

- Be between the ages of 18 and 60

- Provide written informed consent prior to participation and be given a signed copy of
the informed consent form (ICF).

- Be in good general health as determined by the investigator/designee based on a review
of the Medical history/update for participation in the study;

- Have at least 20 gradable teeth;

- Have 10 or more bleeding sites at Baseline

Exclusion Criteria:

- Known allergies or sensitivity to oral rinse products, especially those containing
cetylpyridinium chloride (CPC), sodium hydroxide or potassium dihydrogen phosphate.

- Severe periodontal disease, as characterized by purulent exudate, generalized
mobility, and/or severe recession.

- Active treatment for periodontitis.

- Braces

- Diabetes

- Antibiotic use within three months of the Baseline, Visit 1.

- Pregnancy

- Any diseases or conditions that could be expected to interfere with the subject safely
completing the study.

Continuance Criteria

Subjects may be excluded from the study or the analysis due to:

- Use of antibiotics any time during the study;

- Use of any non-study oral hygiene products during the study;

- A non-study dental prophylaxis or other elective dentistry during the study