NCT02187016

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

December 29, 2015

Completed
Last Updated

March 8, 2016

Status Verified

February 1, 2016

Enrollment Period

1 month

First QC Date

July 1, 2014

Results QC Date

November 23, 2015

Last Update Submit

February 5, 2016

Conditions

Gingivitis

Keywords

Gingivitisplaqueinterproximal cleaningdental floss

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14

    MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).

    14 days

Secondary Outcomes (5)

  • Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28

    28 days

  • Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14

    14 days

  • Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28

    28 days

  • Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14

    14 days

  • Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28

    28 days

Study Arms (4)

AirFloss + BreathRx

EXPERIMENTAL

Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with BreathRx rinse once a day.

Device: AirFloss + BreathRx

AirFloss + Listerine

EXPERIMENTAL

Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device with Listerine Cool Mint rinse once a day.

Device: AirFloss + Listerine

Dental Floss

EXPERIMENTAL

Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day.

Device: Dental Floss

Manual Toothbrush

ACTIVE COMPARATOR

Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute

Device: Manual Toothbrush

Interventions

AirFloss + BreathRxDEVICE

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.

AirFloss + BreathRx
AirFloss + ListerineDEVICE

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.

AirFloss + Listerine
Dental FlossDEVICE

Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.

Dental Floss
Manual ToothbrushDEVICE

Manual Toothbrush used twice daily, 1 minute.

Manual Toothbrush

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be willing and physically able to carry out all study procedures and be available at all times required for participation
  • Be able to fully understand and comply with the written and verbal instructions provided
  • Provide written Informed Consent
  • Be age 18 - 65 years
  • Agree to return study materials at the required visits
  • Be a non-smoker
  • Have a minimum of 20 'scorable' teeth (excluding 3rd molars)
  • Have a minimum average plaque score of \> 0.5 per RMNPI scoring with 2-6 hours of plaque accumulation
  • Have a Gingival Bleeding Index of -\>1 on at least 10 sites
  • Be a regular manual toothbrush user
  • Be a non or irregular flosser defined as using dental floss or any other interproximal cleaning technique once per week or less often

You may not qualify if:

  • A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion
  • Pregnant or nursing per subject report
  • A medical condition requiring antibiotic pre-medication prior to dental appointments
  • Diagnosis of xerostomia
  • Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth
  • Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator /Examiner discretion
  • Oral surgery within the last 2 months
  • Current use of professionally dispensed bleaching products
  • A known allergy or sensitivity to products planned for use in this study
  • Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study
  • Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study
  • Participation in an oral care study within the previous 90 days
  • Be an employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm
  • Are a dental student or dental professional
  • A cardiac pacemaker or implanted cardiac defibrillator
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silverstone Research Group

Las Vegas, Nevada, 89146, United States

Location

MeSH Terms

Conditions

GingivitisPlaque, Amyloid

Interventions

Dental Devices, Home Care

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental EquipmentDentistryOral HygienePreventive DentistryEquipment and Supplies

Results Point of Contact

Title
Pejjmon Amini, DMD
Organization
Silverstone Research Group
702-901-444

Study Officials

  • Pejmon Amini, DDS

    Silverston Research Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 10, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 8, 2016

Results First Posted

December 29, 2015

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)