GingivitisNCT02883244
Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis
A study testing Soft-Picks Advanced and Floss in people with Gingivitis, run by Sunstar Americas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Soft-Picks Advanced and Floss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Periodontology UNC School of Dentistry
Chapel Hill, North Carolina, 27599-7450
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Soft-Picks Advanced, Floss
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft-Picks AdvancedDevice
Soft-picks Advanced will be used once a day to clean interdental sites at home.
FlossDevice
Floss will be used once a day to clean interdental sites at home.
| Study group | Role | What they receive |
|---|---|---|
| Soft-Picks Advanced | Experimental | Device: Curved Soft-Picks Receives: Device: Soft-Picks Advanced |
| Floss | Active comparator | Device: Waxed tape floss Receives: Device: Floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Baseline and 28 days
Secondary outcomes (4)
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).
Measured: 28 days
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)
Measured: Baseline and 28 days
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)
Measured: Baseline and 28 days
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)
Measured: Baseline and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunstar Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio Moretti, DDS, MS, Principal investigator, Clinical Associate Professor and Graduate Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883244
- Sponsor's protocol ID
- CLP-2015-11-16-1
- Status last verified
- May 2017
- First submitted
- 25 Aug 2016
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Curved Design Soft-Picks on Plaque Accumulation on Patients With Signs of Gingivitis
- ClinicalTrials.gov ID
- NCT02883244
- Acronym / sponsor ID
- CLP-2015-11-16-1
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sunstar AmericasIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Posted 16 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soft-Picks Advanced | Experimental | Device: Soft-Picks AdvancedDevice: Curved Soft-Picks |
| Floss | Active comparator | Device: FlossDevice: Waxed tape floss |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft-Picks AdvancedSoft-picks Advanced will be used once a day to clean interdental sites at home. | Device | Soft-Picks Advanced |
| FlossFloss will be used once a day to clean interdental sites at home. | Device | Floss |
Primary outcome
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)
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)
4 secondary outcomes
Performance (Easy to Use) of an Assigned Product
Time frame: 28 days
Change in Gingivitis by UNC Modified Gingival Index at 28 Days
Time frame: Baseline and 28 days
Change in Gingivitis by Bleeding on Probing at 28 Days
Time frame: Baseline and 28 days
Change in Gingivitis by Probing Pocket Depth at 28 Days
Time frame: Baseline and 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Moretti, DDS, MS principal investigator
Clinical Associate Professor and Graduate Program Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft-Picks Advanced and Floss in people with Gingivitis, run by Sunstar Americas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days (time frame: Baseline and 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018; AzTrials last refreshed its copy on 6 Nov 2026.