NCT03154021

Next Science Antimicrobial Mouth Rinse Study

Clinical Effectiveness of Next Science Oral Rinse in Controlling Plaques and Gingival Inflammation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gingivitis
• Dental Plaque

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Next Science OTC Oral Rinse with Essential Oils	This group will receive Next Science Oral Rinse with Essential Oils and the other half will be give OTC Oral Rinse Control
COMBINATION_PRODUCT	OTC Oral Rinse Control	This group will receive OTC Oral Rinse Control

Timeline

• Start date: 2017-08-28
• Primary completion: 2018-03-08
• Completion: 2018-05-15
• First posted: 2017-05-15
• Last updated: 2019-02-18

Locations

2 sites across 1 country: United States