Philips AirFlosser Study
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque|
- The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group [ Time Frame: Four Months ] [ Designated as safety issue: No ]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.
- Gingival Inflammation [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]Assess the safety of the Sonicare AirFloss + MTB treatment.
- Percentage of Bleeding Sites [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Use of Airflosser
Use of Philips Airflosser
Other Name: Philips Airflosser
Active Comparator: Manual Floss
Device: Manual Floss
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700348
|United States, Massachusetts|
|Tufts University School of Dental Medicine|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Gerard Kugel, DMD, MS, PhD||TUSDM|