NCT02836223

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

July 1, 2016

Enrollment Period

1 month

First QC Date

July 14, 2016

Last Update Submit

October 31, 2016

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

  • Reduction of gingival bleeding

    4 weeks

Secondary Outcomes (2)

  • Reduction of gingival inflammation

    4 weeks

  • Reduction in dental plaque

    4 weeks

Study Arms (2)

Interdental device

EXPERIMENTAL

Water Flosser

Device: Interdental cleaning deviceDevice: Manual Tooth brush

Toothbrush

OTHER

Control

Device: Manual Tooth brush

Interventions

Interdental cleaning deviceDEVICE

Water Flosser

Interdental device
Manual Tooth brushDEVICE

Control

Interdental deviceToothbrush

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All Sum Research Center Ltd.

Mississauga, Ontario, L4W 0C2, Canada

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 18, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)