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OpenTrials
Completed

NCT Number: NCT03049761

Water Flosser vs String Floss vs Manual Toothbrush Safety

Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings

Completed

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Key information

Conditions

Soft Tissue Injuries Wounds and Injuries

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study is designed to add to the safety data by measuring, Oral Soft tissue, Clinical Attachment Levels and Probing Pocket Depths on different pressure settings at different time points over a 6 week period. Data will be collected at Baseline, 2 week, 4 week and 6 week time frames.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written consent prior to participation
  • Good general health and non smoker
  • Have scorable Ramfjord's teeth

Exclusion criteria

  • Probing depth >4mm on Ramfjord's teeth
  • Moderate to severe gingivitis
  • Advanced periodontitis
  • Medications that impact soft tissue.

Treatment and study plan

Water Flosser

Device

Power interdental cleaner

String Floss

Device

Mechanical interdental cleaner

Manual toothbrush

Device

ADA standard soft bristle toothbrush

Primary outcomes

  1. Clinical Attachment Levels

    Time frame: 6 weeks

    Measurement from the junction Epithelium to the cemento enamel junction

Secondary outcomes

  1. Probing pocket depth

    Time frame: 6 weeks

    Measurement from the junction Epithelium to the free gingival margin

Sponsors and collaborators

Lead sponsor

All Sum Research Center Ltd.

Other

Collaborators

  • Water Pik, Inc.

Registry information

Official study title

Evaluation of the Safety of a Water Flosser on Gingival and Epithelial Tissue at Different Pressure Settings

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2017
Registry last updated
Jan 10, 2019

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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