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Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

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ClinicalTrials.gov Identifier: NCT02187016
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : December 29, 2015
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Philips Oral Healthcare

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.

Condition or disease Intervention/treatment Phase
Gingivitis Device: AirFloss + BreathRx Device: AirFloss + Listerine Device: Dental Floss Device: Manual Toothbrush Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health
Drug Information available for: Listerine

Arm Intervention/treatment
Experimental: AirFloss + BreathRx
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
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.

Experimental: AirFloss + Listerine
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
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.

Experimental: Dental Floss
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 used twice daily, 1 minute. Interproximal cleaning used once daily.

Active Comparator: Manual Toothbrush
Device: Subjects brushed with a ADA Reference Manual Toothbrush once a day for 1 minute
Device: Manual Toothbrush
Manual Toothbrush used twice daily, 1 minute.




Primary Outcome Measures :
  1. Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 [ Time Frame: 14 days ]
    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 :
  1. Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 [ Time Frame: 28 days ]
    MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).

  2. Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 [ Time Frame: 14 days ]
    GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).

  3. Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 [ Time Frame: 28 days ]
    GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).

  4. Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 [ Time Frame: 14 days ]
    RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).

  5. Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 [ Time Frame: 28 days ]
    RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187016


Locations
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United States, Nevada
Silverstone Research Group
Las Vegas, Nevada, United States, 89146
Sponsors and Collaborators
Philips Oral Healthcare
Investigators
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Principal Investigator: Pejmon Amini, DDS Silverston Research Group

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Responsible Party: Philips Oral Healthcare
ClinicalTrials.gov Identifier: NCT02187016     History of Changes
Other Study ID Numbers: MAH-13-0151
First Posted: July 10, 2014    Key Record Dates
Results First Posted: December 29, 2015
Last Update Posted: March 8, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Philips Oral Healthcare:
Gingivitis
plaque
interproximal cleaning
dental floss

Additional relevant MeSH terms:
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Listerine
Sodium Fluoride
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs