Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00855933
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : February 8, 2013
Last Update Posted : February 8, 2013
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Gingivitis
Intervention Device: Experimental Floss
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brushing Only Brushing + Flossing
Hide Arm/Group Description Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily. Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
Period Title: Overall Study
Started 30 30
Completed 30 29
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Arm/Group Title Brushing Only Brushing + Flossing Total
Hide Arm/Group Description Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily. Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
29.5  (10.08) 27.8  (9.41) 28.7  (9.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
26
  86.7%
27
  90.0%
53
  88.3%
Male
4
  13.3%
3
  10.0%
7
  11.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Guatemala Number Analyzed 30 participants 30 participants 60 participants
30 30 60
Whole Mouth Average Lobene Modified Gingival Index  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 30 participants 30 participants 60 participants
2.41  (0.28) 2.38  (0.27) 2.40  (0.27)
1.Primary Outcome
Title Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale
Hide Description

A whole-mouth average Lobene Modified Gingival Index was calculated by summing the scores and dividing by the number of sites graded (excludes missing teeth & sites not graded). Whole mouth average can range from 0 (normal) to 4 (severe inflammation).

For each tooth, six gingival areas (distobuccal, buccal, mesiobuccal, mesiolingual, lingual, and distolingual) were scored using the following scale: 0=Normal (Absence of inflammation, 1=Mild inflammation (slight change in color, little change in texture) of any portion of but not the entire marginal or papillary gingival unit, 2=Mild inflammation criteria as above but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the marginal or papillary gingival unit, 4=Severe inflammation (marked redness, edema and/or hypertrophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brushing Only Brushing + Flossing
Hide Arm/Group Description:
Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
Overall Number of Participants Analyzed 30 30
Mean (Standard Error)
Unit of Measure: units on a scale
1.84  (0.047) 1.73  (0.047)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brushing Only, Brushing + Flossing
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments a priori threshold for statistical significance = 0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
-0.03 to 0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.066
Estimation Comments 2-sided with the significance level set at 5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brushing Only Brushing + Flossing
Hide Arm/Group Description Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily. Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
All-Cause Mortality
Brushing Only Brushing + Flossing
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Brushing Only Brushing + Flossing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Brushing Only Brushing + Flossing
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jon Witt
Organization: The Procter & Gamble Co.
Phone: 513-622-2963
EMail: witt.jj.2@pg.com
Layout table for additonal information
Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00855933    
Other Study ID Numbers: 2008110
First Submitted: March 3, 2009
First Posted: March 5, 2009
Results First Submitted: December 3, 2012
Results First Posted: February 8, 2013
Last Update Posted: February 8, 2013