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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04197427
• Other study ID #: SW-101-19
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: You First Services
• Contact: Sebastian Ciancio, D.D.S
• Phone: 716-829-3848
• Email: ciancio[@]buffalo.ed
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

This clinical study design is a randomized, double-blind, single-treatment, parallel design with a placebo as the control. Following a screening exam, the duration of the trial will be 1 month. Oral examinations will occur at Visit 1 (baseline), and Visit 2 (4 weeks post screening). Also, at these visits, subjects will be asked keep a diary for the one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of "freshness". They will also be asked about the taste and consistency of the mouth rinse. Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). Gingival health will be measured using the Modified Gingival Index (MGI)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Gingivitis
• Plaque

Intervention

Device:
• Experimental Oral Rinse
Experimental Oral Rinse is a proprietary formulation of GRAS ingredients
• Placebo
Placebo formulation without the active ingredients

Locations

Country	Name	City	State
United States	Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
You First Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Effectiveness of the oral rinse in reducing gingivitis	Gingival health will be measured using the Modified Gingival Index (MGI)	4 weeks
Primary	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	Safety evaluation of the test Oral Rinse	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	4 weeks