Comparison of Two Interdental Cleaners

Gingivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03047759
• Other study ID #: 2016-WP-2
• Status: Completed
• Phase: N/A
• First received: August 17, 2016
• Last updated: February 7, 2017
• Start date: July 21, 2016
• Est. completion date: August 19, 2016

Study information

• Verified date: August 2016
• Source: All Sum Research Center Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.

Description:

This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks and 4-weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 19, 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy adult

• Non smoker

• Available for 4-weeks

• Able to provide written informed consent.

• Minimum of 20 natural teeth.

• Minimum requirement for plaque, gingivitis and bleeding.

Exclusion Criteria:

• Medical condition

• No antibiotics within 6 months of study start

• Not on any medication (impact oral health).

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• water flosser
Powered
• air floss
Powered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
All Sum Research Center Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding upon probing	Bleeding upon probing	4 weeks
Secondary	Gingivitis	Modified Gingival \index	4 weeks
Secondary	Plaque	Rustogi Modification of the Navy Plaque Index	4 weeks