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OpenTrials
Completed

NCT Number: NCT02836223

Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health

This study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival bleeding and reduction of gingival inflammation.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All Sum Research Center Ltd.

Mississauga, Ontario, L4W 0C2, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 25 and 70 years of age
  • Able to provide written informed consent prior to participation
  • Agree to not participate in any other oral/dental products clinical study for the study duration
  • Good general health and be a non-smoker
  • A minimum of 50% bleeding on probing sites
  • A minimum pre-brushing plaque score of 0.6
  • A minimum of 1.75 gingivitis score Have no probing depths greater than 5 mm
  • A minimum of 20 teeth (not including 3rd molars)
  • No partial dentures, orthodontic brackets, wires or other appliances
  • Agree to refrain from the use of any non-study dental device or oral care product for the study duration
  • Agree to return for the scheduled visits and follow study procedures
  • Agree to delay dental prophylaxis until study completion
  • Have a minimum pre-brushing plaque score of 0.6
  • Have a minimum of 1.75 gingivitis score

Exclusion criteria

  • Probing depth greater than 5 mm
  • Systemic disease (ex. Diabetes, autoimmune disease)
  • Advanced periodontitis
  • Taking medication that can influence gingival health such as seizure meds, calcium channel blockers, Cyclosporine, anticoagulants
  • Orthodontic appliances or removable partial dentures
  • Pregnant at time of study
  • Use of antibiotics within 6 months of study

Treatment and study plan

Interdental cleaning device

Device

Water Flosser

Manual Tooth brush

Device

Control

Primary outcomes

  1. Reduction of gingival bleeding

    Time frame: 4 weeks

Secondary outcomes

  1. Reduction of gingival inflammation

    Time frame: 4 weeks

  2. Reduction in dental plaque

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Water Pik, Inc.

Industry

Collaborators

  • All Sum Research Center Ltd.

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2016
Registry last updated
Nov 1, 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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