Skip to main content
OpenTrials
Completed

NCT Number: NCT01250769

Evaluating the Effect of Tooth Cleaning Devices on Oral Health

This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning modalities on oral health.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Park Research Center

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • are in good/excellent health;
  • are 18 - 70 years old;
  • have a minimum of 20 natural teeth (excluding 3rd molars);
  • have sufficient test sites;
  • have ≥ 20 bleeding sites;
  • are willing to participate and available for participation.

Exclusion criteria

  • have systemic diseases such as Down's syndrome, or known AIDS/HIV;
  • have insulin dependant Diabetes;
  • are pregnant or nursing by subject report;
  • have a cardiac pacemaker
  • are undergoing or require extensive dental or orthodontic treatment;
  • require antibiotic treatment for dental appointments;
  • have heavy deposits of calculus;
  • have severe gingivitis or periodontitis;
  • have extensive crown or bridge work and/or rampant decay;
  • currently use bleaching trays;
  • have any oral or extraoral piercing on lips or in mouth;
  • have a professional prophylaxis within 4 weeks of study;
  • participation in a prior study ≤ 20 days;
  • employed by a oral healthcare products company or research institution.

Treatment and study plan

Manual toothbrush

Device

A standard size manual toothbrush to clean visible tooth surfaces

Other names: ADA Reference Toothbrush

Interproximal Cleaning Device

Device

An electronic device that combines water and air to clean between the teeth

Other names: Philips AirFloss

Primary outcomes

  1. Residual Protein Concentration

    Time frame: 14 days

    Residual protein concentration of interproximal plaque samples

Secondary outcomes

  1. Residual Protein Concentration

    Time frame: 28 days

    Residual protein concentration of interproximal plaque samples

  2. Modified Gingival Index

    Time frame: 14 days

    Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)

  3. Modified Gingival Index

    Time frame: 28 days

    Gingival inflammation evaluation on an ordinal scale of 0 to 4 (0 is best ; 4 is worst)

  4. Gingival Bleeding Index

    Time frame: 14 days

    Gingival bleeding evaluation using an ordinal scale of 0 to 3; (0 is best; 3 is worst)

  5. Gingival Bleeding Index

    Time frame: 28 days

    Gingival bleeding evaluation using a ordinal scale of 0 to 3; (0 is best; 3 is worst)

Sponsors and collaborators

Lead sponsor

Philips Oral Healthcare

Industry

Registry information

Official study title

Evaluating the Effect of a Novel Interproximal Cleaning Device on Oral Health

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 1, 2010
Registry last updated
Sep 19, 2012

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.

Published trials that share one or more normalized conditions with this study.