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Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soft-Picks Advanced
Floss
Sponsored by
Sunstar Americas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Periodontology UNC School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Soft-Picks Advanced

Floss

Arm Description

Device: Curved Soft-Picks

Device: Waxed tape floss

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Performance (Easy to Use) of an Assigned Product
Subjects record product performance and experience on a diary. Scale of Easy to Use was scored from 1 to 5 (1= Not easy; 5= Very easy).
Change in Gingivitis by UNC Modified Gingival Index at 28 Days
Gingiva shall be assessed at 6 sites per tooth: distobuccal, direct buccal, mesiobuccal, distolingual, direct lingual and mesiolingual surfaces (Scale is 0-3: 0 =Normal gingiva (pink, firm, stippled), 3 =Severe inflammation: marked redness and edema, ulceration, tendency to spontaneous bleeding). Change = (28 days Score - Baseline Score)
Change in Gingivitis by Bleeding on Probing at 28 Days
Presence or absence of bleeding within 10 seconds after probing shall be scored at 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces. The number of sites where bleeding is recorded is divided by the total number of available sites and multiplied by 100 to express the bleeding on probing as a percentage. Change = (28 days percentage - Baseline percentage)
Change in Gingivitis by Probing Pocket Depth at 28 Days
6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces: (mm) Change = (28 days measurement - Baseline measurement)

Full Information

First Posted
August 25, 2016
Last Updated
November 16, 2018
Sponsor
Sunstar Americas
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1. Study Identification

Unique Protocol Identification Number
NCT02883244
Brief Title
Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis
Official Title
Effect of Curved Design Soft-Picks on Plaque Accumulation on Patients With Signs of Gingivitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunstar Americas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soft-Picks Advanced
Arm Type
Experimental
Arm Description
Device: Curved Soft-Picks
Arm Title
Floss
Arm Type
Active Comparator
Arm Description
Device: Waxed tape floss
Intervention Type
Device
Intervention Name(s)
Soft-Picks Advanced
Intervention Description
Soft-picks Advanced will be used once a day to clean interdental sites at home.
Intervention Type
Device
Intervention Name(s)
Floss
Intervention Description
Floss will be used once a day to clean interdental sites at home.
Primary Outcome Measure Information:
Title
Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days
Description
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)
Time Frame
Baseline and 14 days
Title
Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 28 Days
Description
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)
Time Frame
Baseline and 28 days
Secondary Outcome Measure Information:
Title
Performance (Easy to Use) of an Assigned Product
Description
Subjects record product performance and experience on a diary. Scale of Easy to Use was scored from 1 to 5 (1= Not easy; 5= Very easy).
Time Frame
28 days
Title
Change in Gingivitis by UNC Modified Gingival Index at 28 Days
Description
Gingiva shall be assessed at 6 sites per tooth: distobuccal, direct buccal, mesiobuccal, distolingual, direct lingual and mesiolingual surfaces (Scale is 0-3: 0 =Normal gingiva (pink, firm, stippled), 3 =Severe inflammation: marked redness and edema, ulceration, tendency to spontaneous bleeding). Change = (28 days Score - Baseline Score)
Time Frame
Baseline and 28 days
Title
Change in Gingivitis by Bleeding on Probing at 28 Days
Description
Presence or absence of bleeding within 10 seconds after probing shall be scored at 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces. The number of sites where bleeding is recorded is divided by the total number of available sites and multiplied by 100 to express the bleeding on probing as a percentage. Change = (28 days percentage - Baseline percentage)
Time Frame
Baseline and 28 days
Title
Change in Gingivitis by Probing Pocket Depth at 28 Days
Description
6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces: (mm) Change = (28 days measurement - Baseline measurement)
Time Frame
Baseline and 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Moretti, DDS, MS
Organizational Affiliation
Clinical Associate Professor and Graduate Program Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology UNC School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7450
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis

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