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Trial record 99 of 258 for:    colgate

Efficacy and Safety Study of Interproximal Cleaning Modalities on Oral Health

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ClinicalTrials.gov Identifier: NCT02187016
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : December 29, 2015
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Philips Oral Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Gingivitis
Interventions Device: AirFloss + BreathRx
Device: AirFloss + Listerine
Device: Dental Floss
Device: Manual Toothbrush
Enrollment 290
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Hide Arm/Group Description AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute Manual Toothbrush is used twice a day for 1 minute
Period Title: Overall Study
Started 80 80 79 51
Completed 79 78 78 51
Not Completed 1 2 1 0
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush Total
Hide Arm/Group Description AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute Manual Toothbrush is used twice a day for 1 minute Total of all reporting groups
Overall Number of Baseline Participants 79 78 79 51 287
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 79 participants 78 participants 79 participants 51 participants 287 participants
37  (12.20) 35.6  (10.70) 34.9  (11.00) 35.1  (12.10) 35.7  (11.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 79 participants 78 participants 79 participants 51 participants 287 participants
Female
50
  63.3%
50
  64.1%
51
  64.6%
33
  64.7%
184
  64.1%
Male
29
  36.7%
28
  35.9%
28
  35.4%
18
  35.3%
103
  35.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 79 participants 78 participants 79 participants 51 participants 287 participants
79 78 79 51 287
1.Primary Outcome
Title Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
Hide Description MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Hide Arm/Group Description:
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
Manual Toothbrush is used twice a day for 1 minute
Overall Number of Participants Analyzed 79 78 79 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.10  (0.01) 0.10  (0.01) 0.10  (0.01) 0.01  (0.01)
2.Secondary Outcome
Title Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
Hide Description MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Hide Arm/Group Description:
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
Manual Toothbrush is used twice a day for 1 minute
Overall Number of Participants Analyzed 79 78 78 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.20  (0.01) 0.22  (0.01) 0.26  (0.01) 0.03  (0.02)
3.Secondary Outcome
Title Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
Hide Description GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Hide Arm/Group Description:
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
Manual Toothbrush is used twice a day for 1 minute
Overall Number of Participants Analyzed 79 78 79 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.05  (0.00) 0.05  (0.00) 0.05  (0.00) 0.00  (0.01)
4.Secondary Outcome
Title Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
Hide Description GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Hide Arm/Group Description:
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
Manual Toothbrush is used twice a day for 1 minute
Overall Number of Participants Analyzed 79 78 78 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.08  (0.00) 0.08  (0.00) 0.09  (0.00) 0.01  (0.01)
5.Secondary Outcome
Title Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
Hide Description RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Hide Arm/Group Description:
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
Manual Toothbrush is used twice a day for 1 minute
Overall Number of Participants Analyzed 79 78 79 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.09  (0.01) 0.10  (0.01) 0.11  (0.01) 0.04  (0.01)
6.Secondary Outcome
Title Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
Hide Description RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Hide Arm/Group Description:
AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
Manual Toothbrush is used twice a day for 1 minute
Overall Number of Participants Analyzed 79 78 78 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.15  (0.01) 0.16  (0.01) 0.17  (0.01) 0.04  (0.01)
Time Frame Oral changes from baseline evaluated at Day 14 and 28
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Hide Arm/Group Description AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute Manual Toothbrush is used twice a day for 1 minute
All-Cause Mortality
AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/79 (0.00%)   0/78 (0.00%)   0/78 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AirFloss + Rinse1 AirFloss + Rinse2 String Floss Manual Toothbrush
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/79 (2.53%)   1/78 (1.28%)   1/78 (1.28%)   0/51 (0.00%) 
Injury, poisoning and procedural complications         
Gingival Irritation   2/79 (2.53%)  1/78 (1.28%)  1/78 (1.28%)  0/51 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Pejjmon Amini, DMD
Organization: Silverstone Research Group
Phone: 702-901-444
Responsible Party: Philips Oral Healthcare
ClinicalTrials.gov Identifier: NCT02187016     History of Changes
Other Study ID Numbers: MAH-13-0151
First Submitted: July 1, 2014
First Posted: July 10, 2014
Results First Submitted: November 23, 2015
Results First Posted: December 29, 2015
Last Update Posted: March 8, 2016