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Status unknownNCT04197427Updated Dec 17, 2019

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

An interventional study of Experimental Oral Rinse and Placebo in Plaque and Gingivitis, sponsored by You First Services. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-17.

Sponsored by You First Services · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the detailed 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)

02

Conditions studied

  • Plaque
  • Gingivitis

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03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Experimental Oral Rinse

    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 comparator
    Placebo Oral Rinse

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

    Device: Placebo

Interventions

  • DeviceExperimental Oral Rinse

    Experimental Oral Rinse is a proprietary formulation of GRAS ingredients

  • DevicePlacebo

    Placebo formulation without the active ingredients

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 4 weeks

  2. Effectiveness of the oral rinse in reducing gingivitis

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

    Time frame: 4 weeks

  3. 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",

    Time frame: 4 weeks

Secondary outcomes

  1. Safety evaluation of the test Oral Rinse

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 4 weeks

06

Study locations

1 site
  • Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY
    Buffalo, New York 14214, United States
07

Registry details

Key details

Study ID
NCT04197427
Lead sponsor
You First Services
Responsible party
Sponsor
First posted
Dec 13, 2019
Start date
Mar 1, 2020 (estimated)
Primary completion
Nov 30, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Dec 17, 2019

Study contacts

Sebastian Ciancio, D.D.S
Contact
ciancio@buffalo.ed
716-829-3848

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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