Gingivitis
Conditions
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.
Interventions
DEVICESoft-Picks Advanced
Soft-picks Advanced will be used once a day to clean interdental sites at home.
DEVICEFloss
Floss will be used once a day to clean interdental sites at home.
Sponsors
Sunstar Americas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance (Easy to Use) of an Assigned Product | 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). |
| Change in Gingivitis by UNC Modified Gingival Index at 28 Days | 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) |
| Change in Gingivitis by Bleeding on Probing at 28 Days | 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) |
| Change in Gingivitis by Probing Pocket Depth at 28 Days | Baseline and 28 days | 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces: (mm) Change = (28 days measurement - Baseline measurement) |
Countries
United States
Participant flow
Recruitment details
This study enrolled subjects with signs and symptoms of gingivitis and no or little experience with inter-proximal cleaning device in the single center.
Pre-assignment details
All subjects received professional prophylaxis and assigned manual toothbrush and dentifrice. Group was assigned 3 weeks or more after professional prophylaxis.
Participants by arm
| Arm | Count |
|---|---|
| Soft-Picks Advanced Device: Curved Soft-Picks
Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home. | 26 |
| Floss Device: Waxed tape floss
Floss: Floss will be used once a day to clean interdental sites at home. | 24 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Soft-Picks Advanced | Floss | Total |
|---|---|---|---|
| Age, Continuous | 26.3 years STANDARD_DEVIATION 6.9 | 26.9 years STANDARD_DEVIATION 8.5 | 26.6 years STANDARD_DEVIATION 7.7 |
| Race/Ethnicity, Customized African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized African American, Asian, Caucasian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian/Caucasian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 21 Participants | 16 Participants | 37 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 3 Participants |
| Region of Enrollment United States | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 1 / 26 | 5 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 |
Outcome results
Primary
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)
Time frame: Baseline and 14 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soft-Picks Advanced | Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days | 0.03 score on a scale | Standard Deviation 1.02 |
| Floss | Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days | -0.07 score on a scale | Standard Deviation 1.12 |
Primary
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)
Time frame: Baseline and 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soft-Picks Advanced | Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 28 Days | 0.04 score on a scale | Standard Deviation 1.19 |
| Floss | Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 28 Days | 0.23 score on a scale | Standard Deviation 0.93 |
Secondary
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)
Time frame: Baseline and 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soft-Picks Advanced | Change in Gingivitis by Bleeding on Probing at 28 Days | 7 percentage of Bleeding on Probing | Standard Deviation 21.2 |
| Floss | Change in Gingivitis by Bleeding on Probing at 28 Days | 13 percentage of Bleeding on Probing | Standard Deviation 17.7 |
Secondary
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)
Time frame: Baseline and 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soft-Picks Advanced | Change in Gingivitis by Probing Pocket Depth at 28 Days | -0.16 mm | Standard Deviation 0.21 |
| Floss | Change in Gingivitis by Probing Pocket Depth at 28 Days | 0 mm | Standard Deviation 0.23 |
Secondary
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)
Time frame: Baseline and 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soft-Picks Advanced | Change in Gingivitis by UNC Modified Gingival Index at 28 Days | -0.02 units on a scale | Standard Deviation 0.35 |
| Floss | Change in Gingivitis by UNC Modified Gingival Index at 28 Days | 0.03 units on a scale | Standard Deviation 0.37 |
Secondary
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).
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Soft-Picks Advanced | Performance (Easy to Use) of an Assigned Product | 3.8 score on a scale | Standard Deviation 0.21 |
| Floss | Performance (Easy to Use) of an Assigned Product | 3.37 score on a scale | Standard Deviation 0.17 |