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

W

Water Pik

Status

Completed

Conditions

Gingivitis

Treatments

Device: Manual Tooth brush
Device: Interdental cleaning device

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02836223
16WFVSMTB2016

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups

Interdental device
Experimental group
Description:
Water Flosser
Treatment:
Device: Interdental cleaning device
Device: Manual Tooth brush
Toothbrush
Other group
Description:
Control
Treatment:
Device: Manual Tooth brush

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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