Trial Outcomes & Findings for Philips AirFlosser Study (NCT NCT01700348)

Results Overview

The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

257 participants

Primary outcome timeframe

Four Months

Results posted on

2019-08-06

Participant Flow

Of the 257 subjects who signed consent forms, 140 (54.5% were classified as screen failures). 1 additional subject declined to participate after screening but before randomization.

Participant milestones

Participant milestones
Measure	All Enrolled Subjects Airflosser \& Manual Floss
Overall Study STARTED	116
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled Subjects Airflosser \& Manual Floss
Overall Study Withdrawal by Subject	22
Overall Study Lost to Follow-up	1

Baseline Characteristics

Philips AirFlosser Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Subjects n=116 Participants The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	116 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34.5 years STANDARD_DEVIATION 11.20 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants
Region of Enrollment United States	116 participants n=5 Participants
Number of Missing Teeth	.8 missing teeth STANDARD_DEVIATION 1.40 • n=5 Participants
Average Modified Gingival Index Score	1.2 units on a scale STANDARD_DEVIATION .4 • n=5 Participants
Number of Bleeding Sites	54.1 number of sites STANDARD_DEVIATION 17.80 • n=5 Participants
Percent of Site Bleeding	51.6 percent of sites STANDARD_DEVIATION 16.70 • n=5 Participants

PRIMARY outcome

Timeframe: Four Months

Population: Terminated by financier due to low accrual \& high number of protocol deviations.

The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.