Philips AirFlosser Study

This study has been 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.)
Sponsor:
Collaborators:
Philips Oral Healthcare
Tufts University
Information provided by (Responsible Party):
Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier:
NCT01700348
First received: August 20, 2012
Last updated: May 28, 2015
Last verified: May 2015
Results First Received: February 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Gingivitis
Interventions: Device: Airflosser
Device: Manual Floss

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
All Enrolled Subjects Airflosser & Manual Floss

Participant Flow:   Overall Study
    All Enrolled Subjects  
STARTED     116  
COMPLETED     93  
NOT COMPLETED     23  
Withdrawal by Subject                 22  
Lost to Follow-up                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Data cannot be provided for each arm separately, but only in aggregate

Reporting Groups
  Description
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.

Baseline Measures
    All Randomized Subjects  
Number of Participants  
[units: participants]
  116  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     116  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  34.5  (11.20)  
Gender  
[units: participants]
 
Female     74  
Male     42  
Region of Enrollment  
[units: participants]
 
United States     116  
Number of Missing Teeth  
[units: missing teeth]
Mean (Standard Deviation)
  .8  (1.40)  
Average Modified Gingival Index Score [1]
[units: units on a scale]
Mean (Standard Deviation)
  1.2  (.4)  
Number of Bleeding Sites  
[units: number of sites]
Mean (Standard Deviation)
  54.1  (17.80)  
Percent of Site Bleeding  
[units: percent of sites]
Mean (Standard Deviation)
  51.6  (16.70)  
[1]

The Modified Gingival Index (MGI) scale 0 = absence of inflammation;

  1. = mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary;
  2. = mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary;
  3. = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary;
  4. = severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration.



  Outcome Measures

1.  Primary:   The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group   [ Time Frame: Four Months ]

2.  Secondary:   Gingival Inflammation   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Number of Bleeding Sites   [ Time Frame: 2 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Plaque   [ Time Frame: 4 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: 4 Months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Percentage of Bleeding Sites   [ Time Frame: 2 Weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Terminated by sponsor due to:

  • Changes in business strategy/Target completion dates not being met
  • Higher than anticipated screen failure rate
  • Higher than anticipated early termination rate
  • Large number of protocol deviations encountered


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marcia Delaurenti, Clinical Project Manager
Organization: Philips Oral Healthcare, Inc
phone: 425-908-1212
e-mail: marcia.delaurenti@philips.com


No publications provided


Responsible Party: Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier: NCT01700348     History of Changes
Other Study ID Numbers: MAH-12-0081, 10438
Study First Received: August 20, 2012
Results First Received: February 26, 2015
Last Updated: May 28, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board