Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis
Effect of Curved Design Soft-Picks on Plaque Accumulation on Patients With Signs of Gingivitis
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2016
CompletedFirst Posted
Study publicly available on registry
August 30, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
November 16, 2018
CompletedDecember 11, 2018
May 1, 2017
5 months
August 25, 2016
October 19, 2018
November 16, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days
Plaque scores shall be visually assessed at the four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying interproximal test units: mesiobuccal and distobuccal (scale of 0-5, 0 =No debris or stain present on the clinical crown; 5=Plaque coverage over more than two third of the tooth surface). Change = (14 days Score - Baseline Score)
Baseline and 14 days
Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 28 Days
Plaque scores shall be visually assessed at the four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying interproximal test units: mesiobuccal and distobuccal (scale of 0-5, 0 =No debris or stain present on the clinical crown; 5=Plaque coverage over more than two third of the tooth surface) Change = (28 days Score - Baseline Score)
Baseline and 28 days
Secondary Outcomes (4)
Performance (Easy to Use) of an Assigned Product
28 days
Change in Gingivitis by UNC Modified Gingival Index at 28 Days
Baseline and 28 days
Change in Gingivitis by Bleeding on Probing at 28 Days
Baseline and 28 days
Change in Gingivitis by Probing Pocket Depth at 28 Days
Baseline and 28 days
Study Arms (2)
Soft-Picks Advanced
EXPERIMENTALDevice: Curved Soft-Picks
Floss
ACTIVE COMPARATORDevice: Waxed tape floss
Interventions
Soft-picks Advanced will be used once a day to clean interdental sites at home.
Eligibility Criteria
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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sunstar Americaslead
Study Sites (1)
Department of Periodontology UNC School of Dentistry
Chapel Hill, North Carolina, 27599-7450, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Manager of R&D
- Organization
- Sunstar Americas, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Moretti, DDS, MS
Clinical Associate Professor and Graduate Program Director
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2016
First Posted
August 30, 2016
Study Start
December 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
December 11, 2018
Results First Posted
November 16, 2018
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share