Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis

Sunstar

Status

Completed

Conditions

Gingivitis

Treatments

Device: Floss

Device: Soft-Picks Advanced

Study type

Interventional

Funder types

Industry

Identifiers

NCT02883244

CLP-2015-11-16-1

Details and patient eligibility

About

The aim of this study is to evaluate the efficacy of a new interdental cleaning device (Soft-Picks Advanced), as compared to a leading brand floss; and, how ease of use can promote the establishment of a hygienic routine of cleaning interproximal spaces.

Full description

The Soft-Picks Advanced has a new curved design allowing a user to easily access to difficult interdental sites, such as spaces between premolars and molars. This study is a single center with parallel design, single blinded, which will randomize eligible subjects into two treatment groups.

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be willing and physically able to carry out all study procedures and be available at all times required for participation
Be able to fully understand and comply with the written and verbal instructions provided
Provide written Informed Consent
Be age 18 - 70 years
Agree to return study materials at the required visit(s)
Have a minimum of 20 'scorable' teeth (excluding 3rd molars)
Have more than or equal 10% and less than or equal to 50% Bleeding on Probing (BOP) sites
Have all Pocket Depth (PD) less than or equal to 4mm
Have at least 12 qualifying, interproximal sites (6 per side) with closed contacts, without crown or restorations. (See section 5.1.1 'Teeth Selection')
Be a regular manual toothbrush user for at least 2 months.
Be a non-smoker for at least 2 years.
Be willing to abstain from use of chewing gum and consumption of apples, carrots or other hard crunchy foods or thick skinned fruits for 3-6 hours before each visit.
Be willing to comply with 12-18 hours of no oral hygiene practices

Exclusion criteria

Medical or Dental condition that would be unduly affected by participation in this study, per Investigator Discretion
Pregnant or nursing, per urine based pregnancy test
A medical condition requiring antibiotic pre-medication prior to dental appointments
Diagnosis of Xerostomia
Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth
Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator /Examiner discretion
Oral surgery within the last 2 months
A known allergy or sensitivity to products planned for use in this study
Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study
Participation in an oral care study within the previous 90 days
Are a dental student or dental professional
Uncontrolled Diabetes
Current use of antibiotic medications or use within 4 weeks of enrollment
Presence of heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
Extensive crown or bridge work, rampant decay or excessive gingival recession, per Investigator/Examiner discretion
Presence of orthodontic bands interfering with efficacy outcome(s) per Investigator/Examiner discretion
Current use of professionally dispensed bleaching products or use within one month of screening.
Be an employee, spouse or a relative of an employee of the clinical research site, or a dental products manufacturing, research or marketing firm.
Chronic treatment with any medication known to affect periodontal status within one month of the screening examination (daily use of 81 mg Aspirin is not exclusionary)
Have any tooth sites with: > 5mm PD or attachment loss > 3mm, excluding 3rd molars