Trial Outcomes & Findings for Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis (NCT NCT02883244)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

Baseline and 14 days

Results posted on

2018-12-11

Participant Flow

This study enrolled subjects with signs and symptoms of gingivitis and no or little experience with inter-proximal cleaning device in the single center.

All subjects received professional prophylaxis and assigned manual toothbrush and dentifrice. Group was assigned 3 weeks or more after professional prophylaxis.

Participant milestones

Participant milestones
Measure	Floss Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.	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.
Overall Study STARTED	24	26
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Floss Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.	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.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Soft-Picks Advanced n=26 Participants Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home.	Floss n=24 Participants Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.	Total n=50 Participants Total of all reporting groups
Age, Continuous	26.3 years STANDARD_DEVIATION 6.9 • n=93 Participants	26.9 years STANDARD_DEVIATION 8.5 • n=4 Participants	26.6 years STANDARD_DEVIATION 7.7 • n=27 Participants
Sex: Female, Male Female	13 Participants n=93 Participants	12 Participants n=4 Participants	25 Participants n=27 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	12 Participants n=4 Participants	25 Participants n=27 Participants
Race/Ethnicity, Customized African American	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized African American, Asian, Caucasian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized American Indian/Caucasian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	21 Participants n=93 Participants	16 Participants n=4 Participants	37 Participants n=27 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	26 Participants n=93 Participants	24 Participants n=4 Participants	50 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Soft-Picks Advanced n=26 Participants Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home.	Floss n=24 Participants Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.
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	-0.07 score on a scale Standard Deviation 1.12

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Soft-Picks Advanced n=25 Participants Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home.	Floss n=24 Participants Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.
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	0.23 score on a scale Standard Deviation 0.93

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Soft-Picks Advanced n=25 Participants Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home.	Floss n=24 Participants Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.
Performance (Easy to Use) of an Assigned Product	3.8 score on a scale Standard Deviation 0.21	3.37 score on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Soft-Picks Advanced n=25 Participants Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home.	Floss n=24 Participants Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.
Change in Gingivitis by UNC Modified Gingival Index at 28 Days	-0.02 units on a scale Standard Deviation 0.35	0.03 units on a scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Soft-Picks Advanced n=25 Participants Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home.	Floss n=24 Participants Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.
Change in Gingivitis by Bleeding on Probing at 28 Days	7 percentage of Bleeding on Probing Standard Deviation 21.2	13 percentage of Bleeding on Probing Standard Deviation 17.7

SECONDARY outcome

Timeframe: Baseline and 28 days

6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces: (mm) Change = (28 days measurement - Baseline measurement)

Outcome measures

Outcome measures
Measure	Soft-Picks Advanced n=25 Participants Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home.	Floss n=24 Participants Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.
Change in Gingivitis by Probing Pocket Depth at 28 Days	-0.16 mm Standard Deviation 0.21	0 mm Standard Deviation 0.23

Adverse Events

Soft-Picks Advanced

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Floss

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Soft-Picks Advanced n=26 participants at risk Device: Curved Soft-Picks Soft-Picks Advanced: Soft-picks Advanced will be used once a day to clean interdental sites at home.	Floss n=24 participants at risk Device: Waxed tape floss Floss: Floss will be used once a day to clean interdental sites at home.
Respiratory, thoracic and mediastinal disorders Cold	3.8% 1/26 • Number of events 1 • 28 days	8.3% 2/24 • Number of events 3 • 28 days
Infections and infestations Ingrown toenail	0.00% 0/26 • 28 days	4.2% 1/24 • Number of events 1 • 28 days
Injury, poisoning and procedural complications Finger dislocating	0.00% 0/26 • 28 days	4.2% 1/24 • Number of events 1 • 28 days
Musculoskeletal and connective tissue disorders Torn hamstring	0.00% 0/26 • 28 days	4.2% 1/24 • Number of events 1 • 28 days

Additional Information

Senior Manager of R&D

Sunstar Americas, Inc.

Phone: 8477944276

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. PI shall delay publications for up to 60 days to allow sufficient time to resolve any questions or seek patent protection.
Publication restrictions are in place

Restriction type: OTHER