Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health

NCT04197427 | Unknown DMC FDA Device

• 1 other identifier: SW-101-19
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath

Conditions

Plaque; Gingivitis

Outcome Measures

Primary Outcomes (3)

• Effectiveness of the oral rinse in reducing plaque

  Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI).

  4 weeks

• Effectiveness of the oral rinse in reducing gingivitis

  Gingival health will be measured using the Modified Gingival Index (MGI)

  4 weeks

• Effectiveness of the oral rinse in improving a patient's breath

  Subjects will be asked keep a diary for one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness",

  4 weeks

Secondary Outcomes (1)

• Safety evaluation of the test Oral Rinse

  4 weeks

Study Arms (2)

Experimental Oral Rinse

EXPERIMENTAL

In this arm the test article,oral rinse, a proprietary formulation of agents including xylitol, Caffeine, Essential oils, Monk fruit extract, which can reduce the plaque formation Subjects rinse twice a day with 10 mL of the oral rinse for 2 minutes for 30 days. They will note, in the daily oral hygiene diary, the date and time of brushing and rinsing.

Device: Experimental Oral Rinse

Placebo Oral Rinse

PLACEBO COMPARATOR

This arm will use a placebo with out the active ingredients same way the experimental arm do.

Device: Placebo

Interventions

Experimental Oral Rinse DEVICE

Experimental Oral Rinse is a proprietary formulation of GRAS ingredients

Experimental Oral Rinse

Placebo DEVICE

Placebo formulation without the active ingredients

Placebo Oral Rinse

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
• Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
• Subject is between the ages of 18 and 75 years inclusive.
• Subject will not have professional cleaning during the study.
• Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
• Subject has a minimum of 12 natural teeth.
• Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Aim® Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
• Subject agrees to refrain from the use of other oral care products not supplied by the study center
• Subject agrees to be compliant with study procedures.
• Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy

You may not qualify if:

• Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation.
• Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations.
• Subject is between the ages of 18 and 75 years inclusive.
• Subject will not have professional cleaning during the study.
• Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator.
• Subject has a minimum of 12 natural teeth.
• Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Aim® Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study.
• Subject agrees to refrain from the use of other oral care products not supplied by the study center
• Subject agrees to be compliant with study procedures.
• Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy testing at the first and second visit.

Sponsors & Collaborators

• You First Services: lead

Study Sites (1)

Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Plaque, Amyloid; Gingivitis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Sebastian Ciancio, D.D.S

CONTACT

716-829-3848; ciancio@buffalo.ed

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 13, 2019
• Study Start: March 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 17, 2019

Record last verified: 2019-12

Locations

US (1)