Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis

Completed · Not applicable

Conditions studied: Gingivitis

In brief

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.

Key facts

Study ID

NCT02883244

Run by

Sunstar Americas

People needed

50

Starts

2016-12-01

Expected to finish

2017-05-01

Last updated by the study team

2018-12-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Periodontology UNC School of Dentistry — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.