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Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AirFloss + BreathRx
AirFloss + Listerine
Dental Floss
Manual Toothbrush
Sponsored by
Philips Oral Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Gingivitis, plaque, interproximal cleaning, dental floss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Insulin-Dependent Diabetes
  • Current use of antibiotic medications or use within 4 weeks of enrollment
  • Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin > 81 mg daily)
  • Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion
  • Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
  • Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion
  • Presence of orthodontic bands interfering with efficacy outcome(s) per Investigator/Examiner discretion
  • Have a professional prophylaxis within 4 weeks of the study
  • Be a regular power toothbrush user

Sites / Locations

  • Silverstone Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

AirFloss + BreathRx

AirFloss + Listerine

Dental Floss

Manual Toothbrush

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).

Full Information

First Posted
July 1, 2014
Last Updated
February 5, 2016
Sponsor
Philips Oral Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02187016
Brief Title
Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health
Official Title
A Randomized, Parallel Design Study to Assess the Effects of Three Interproximal Cleaning Modalities Versus a Manual Toothbrush Control on Gingivitis and Plaque Following a Period of Home Use
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Oral Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Gingivitis, plaque, interproximal cleaning, dental floss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AirFloss + BreathRx
Arm Type
Experimental
Arm Description
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.
Arm Title
AirFloss + Listerine
Arm Type
Experimental
Arm Description
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.
Arm Title
Dental Floss
Arm Type
Experimental
Arm Description
Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute. Subjects used interproximal cleaning device once a day.
Arm Title
Manual Toothbrush
Arm Type
Active Comparator
Arm Description
Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute
Intervention Type
Device
Intervention Name(s)
AirFloss + BreathRx
Intervention Description
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
Intervention Type
Device
Intervention Name(s)
AirFloss + Listerine
Intervention Description
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
Intervention Type
Device
Intervention Name(s)
Dental Floss
Intervention Description
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.
Intervention Type
Device
Intervention Name(s)
Manual Toothbrush
Intervention Description
Manual Toothbrush used twice daily, 1 minute.
Primary Outcome Measure Information:
Title
Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
Description
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
Description
MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).
Time Frame
28 days
Title
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
Description
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Time Frame
14 days
Title
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
Description
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Time Frame
28 days
Title
Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
Description
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time Frame
14 days
Title
Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
Description
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Insulin-Dependent Diabetes Current use of antibiotic medications or use within 4 weeks of enrollment Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin > 81 mg daily) Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion Presence of orthodontic bands interfering with efficacy outcome(s) per Investigator/Examiner discretion Have a professional prophylaxis within 4 weeks of the study Be a regular power toothbrush user
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pejmon Amini, DDS
Organizational Affiliation
Silverston Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silverstone Research Group
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89146
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

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