Philips AirFlosser Study
|ClinicalTrials.gov Identifier: NCT01700348|
Recruitment Status : Terminated (Study terminated by sponsor due to low accrual, and high number of protocol deviations due in part to the impact of Hurricane Sandy on protocol compliance.)
First Posted : October 4, 2012
Results First Posted : May 29, 2015
Last Update Posted : May 29, 2015
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
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Device: Airflosser Device: Manual Floss||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||257 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Use of Airflosser
Use of Philips Airflosser
Other Name: Philips Airflosser
Active Comparator: Manual Floss
Device: Manual Floss
- The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group [ Time Frame: 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.
- Gingival Inflammation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4 Months ]Assess the safety of the Sonicare AirFloss + MTB treatment.
- Percentage of Bleeding Sites [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700348
|United States, Massachusetts|
|Tufts University School of Dental Medicine|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Gerard Kugel, DMD, MS, PhD||TUSDM|