Gingivitis
Conditions
Keywords
moderate gingivitis
Brief summary
In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No Intervention group and will be given no test products or instruction other than to change none of their typical at home oral hygiene habits. The aim of this study is to investigate how an AF and MTB oral hygiene intervention will affect a population of irregular flossers using the residual protein concentration method as an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices
Interventions
DEVICEAirflosser
Use of Philips Airflosser
DEVICEManual Floss
Active Comparator
Sponsors
Philips Oral Healthcare
Tufts University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
4.1 Inclusion Criteria Subjects accepted into the study must meet the following requirements: * are 18-70 years; * are in generally good health; * have a minimum of 20 natural teeth (excluding 3rd molars); * have 1 qualifying test site in each posterior quadrant; * are a regular manual toothbrush user (prior periodic use of powered toothbrushes in other studies permitted); * Irregular Flossers defined as using dental floss ≤ 2 days a week; * be willing and able to comply with study procedures and be available at all times required for participation; * have a Gingival Bleeding Index \> 1 on at least 20 sites; * be a non-smoker. 4.2
Exclusion criteria
Subjects will be excluded from the study if they; * have systemic diseases such as Down's syndrome, or known AIDS/HIV; * have insulin dependent Diabetes; * are pregnant or nursing by subject report; * have a cardiac pacemaker or AICD; * are undergoing or require extensive dental or orthodontic treatment; * require antibiotic treatment for dental appointments; * have used antibiotics within 4 weeks of enrollment; * are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin); * have heavy deposits of calculus, either supragingival and/or subgingival; * have severe gingivitis or periodontitis; * have extensive crown or bridge work and/or rampant decay; * are currently use bleaching trays; * have any oral or extraoral piercing on lips or in mouth with ornament or accessory; * have a professional prophylaxis within 4 weeks of study; * have participated in a prior study ≤ 20 days; * are employed by an oral healthcare products company or dental research institution.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group | Four Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Inflammation | 4 weeks | Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline. |
| Number of Bleeding Sites | 2 Weeks | Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group. |
| Plaque | 4 Weeks | Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group. |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | 4 Months | Assess the safety of the Sonicare AirFloss + MTB treatment. |
| Percentage of Bleeding Sites | 2 Weeks | Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Subjects 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. | 116 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | All Randomized Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 116 Participants |
| Age, Continuous | 34.5 years STANDARD_DEVIATION 11.2 |
| Average Modified Gingival Index Score | 1.2 units on a scale STANDARD_DEVIATION 0.4 |
| Number of Bleeding Sites | 54.1 number of sites STANDARD_DEVIATION 17.8 |
| Number of Missing Teeth | .8 missing teeth STANDARD_DEVIATION 1.4 |
| Percent of Site Bleeding | 51.6 percent of sites STANDARD_DEVIATION 16.7 |
| Region of Enrollment United States | 116 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 116 |
| serious Total, serious adverse events | 0 / 116 |
Outcome results
Primary
The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group
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.
Time frame: Four Months
Population: Terminated by financier due to low accrual \& high number of protocol deviations.
Secondary
Gingival Inflammation
Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.
Time frame: 4 weeks
Population: The study was terminated early, data were not analyzed and the plaque samples were destroyed.
Secondary
Number of Bleeding Sites
Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.
Time frame: 2 Weeks
Population: The study was terminated early, data were not analyzed and the plaque samples were destroyed.
Secondary
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Assess the safety of the Sonicare AirFloss + MTB treatment.
Time frame: 4 Months
Population: The study was terminated early, data were not analyzed and the plaque samples were destroyed.
Secondary
Percentage of Bleeding Sites
Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.
Time frame: 2 Weeks
Population: The study was terminated early, data were not analyzed and the plaque samples were destroyed.
Secondary
Plaque
Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.
Time frame: 4 Weeks
Population: The study was terminated early, data were not analyzed and the plaque samples were destroyed.