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The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US

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ClinicalTrials.gov Identifier: NCT02360995
Recruitment Status : Completed
First Posted : February 11, 2015
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Dental Plaque
Gingivitis
Interventions: Drug: Triclosan/fluoride toothpaste
Drug: stannous fluoride toothpaste
Drug: fluoride toothpaste
Drug: Fluoride Mouthwash
Drug: cetylpyridinium chloride Mouthwash

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subject recruitment is completed locally by the clinical site

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There is no wash out or pre-assignment of any study product.

Reporting Groups
  Description
Total Toothpaste

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Toothpaste + Mouthwash

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

Control Group

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.


Participant Flow:   Overall Study
    Total Toothpaste   Toothpaste + Mouthwash   Control Group
STARTED   43   43   43 
COMPLETED   41   42   41 
NOT COMPLETED   2   1   2 
Lost to Follow-up                2                0                2 
Withdrawal by Subject                0                1                0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Total Toothpaste

Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).

Toothpaste + Mouthwash

Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash

stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.

Control Group

fluoride toothpaste +fluoride mouthwash

fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.

Total Total of all reporting groups

Baseline Measures
   Total Toothpaste   Toothpaste + Mouthwash   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 43   43   43   129 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.68  (16.85)   44.90  (15.51)   44.39  (13.68)   44.47  (15.26) 
Gender 
[Units: Participants]
       
Female   23   25   24   72 
Male   20   18   19   57 
Region of Enrollment 
[Units: Participants]
       
United States   43   43   43   129 


  Outcome Measures

1.  Primary:   Dental Plaque Scores   [ Time Frame: Baseline ]

2.  Primary:   Dental Plaque Scores   [ Time Frame: 4 weeks ]

3.  Primary:   Dental Plaque Scores   [ Time Frame: 6 weeks ]

4.  Primary:   Gingivitis Scores   [ Time Frame: Baseline ]

5.  Primary:   Gingivitis Scores   [ Time Frame: 4 weeks ]

6.  Primary:   Gingivitis Scores   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 less than or equal to 60 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: Yiming Li, DDS
Organization: Loma Linda University School of Dentistry
phone: 909-558-8069
e-mail: yli@llu.edu



Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02360995     History of Changes
Other Study ID Numbers: CRO-2014-06-PLAGIN-CT-YPZ
First Submitted: February 6, 2015
First Posted: February 11, 2015
Results First Submitted: February 1, 2016
Results First Posted: March 30, 2016
Last Update Posted: March 30, 2016