Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis

November 16, 2018 updated by: Sunstar Americas

Effect of Curved Design Soft-Picks on Plaque Accumulation on Patients With Signs of Gingivitis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7450
        • Department of Periodontology UNC School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Soft-Picks Advanced
Device: Curved Soft-Picks
Device: Soft-Picks Advanced
Soft-picks Advanced will be used once a day to clean interdental sites at home.
Active Comparator: Floss
Device: Waxed tape floss
Device: Floss
Floss will be used once a day to clean interdental sites at home.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days
Time Frame: Baseline and 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
Time Frame: Baseline and 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Performance (Easy to Use) of an Assigned Product
Time Frame: 28 days
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).
28 days
Change in Gingivitis by UNC Modified Gingival Index at 28 Days
Time Frame: Baseline and 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)
Baseline and 28 days
Change in Gingivitis by Bleeding on Probing at 28 Days
Time Frame: Baseline and 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)
Baseline and 28 days
Change in Gingivitis by Probing Pocket Depth at 28 Days
Time Frame: Baseline and 28 days
6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces: (mm) Change = (28 days measurement - Baseline measurement)
Baseline and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunstar Americas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio Moretti, DDS, MS, Clinical Associate Professor and Graduate Program Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLP-2015-11-16-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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