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Completed

NCT Number: NCT02187016

Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Silverstone Research Group

Las Vegas, Nevada, 89146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AirFloss + BreathRx

Device

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

AirFloss + Listerine

Device

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

Dental Floss

Device

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

Manual toothbrush

Device

Manual Toothbrush used twice daily, 1 minute.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Philips Oral Healthcare

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2014
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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