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Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

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ClinicalTrials.gov Identifier: NCT01122862
Recruitment Status : Completed
First Posted : May 13, 2010
Results First Posted : July 30, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Healthy Subjects
Interventions: Drug: 0.12% chlorhexidine mouthrinse
Other: Cosmetic mouthrinse
Other: Sterile water

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at the clinical site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 31 participants screened, 23 were randomized. 8 enrolled participants were excluded from trial before assignment to groups (3 did not meet the study criterion; remaining 5 were excluded due to other reasons).

Reporting Groups
  Description
Test Mouth Rinse Participants swirled their oral cavity with 15 milliliters (mL) of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
Chlorhexidine Mouth Rinse (0.12%) Participants swirled their oral cavity with 15 mL of commercially available 0.12% weight by volume (w/v) chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
Sterile Water Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.

Participant Flow for 3 periods

Period 1:   Period 1
    Test Mouth Rinse   Chlorhexidine Mouth Rinse (0.12%)   Sterile Water
STARTED   8   8   7 
COMPLETED   8   7   7 
NOT COMPLETED   0   1   0 
Protocol Violation                0                1                0 

Period 2:   Period 2
    Test Mouth Rinse   Chlorhexidine Mouth Rinse (0.12%)   Sterile Water
STARTED   8 [1]   7 [1]   7 [1] 
COMPLETED   8   7   6 
NOT COMPLETED   0   0   1 
Adverse Event                0                0                1 
[1] Due to crossover design,a different set of participants received this treatment compared to Period 1

Period 3:   Period 3
    Test Mouth Rinse   Chlorhexidine Mouth Rinse (0.12%)   Sterile Water
STARTED   6 [1]   7 [1]   8 [1] 
COMPLETED   6   7   8 
NOT COMPLETED   0   0   0 
[1] Due to crossover design,a different set of participants received this treatment compared to Period 2



  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
All Randomized Participants All randomized participants were included for baseline parameters evaluation.

Baseline Measures
   All Randomized Participants 
Overall Participants Analyzed 
[Units: Participants]
 23 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.9  (14.62) 
Gender 
[Units: Participants]
 
Female   14 
Male   9 
Mean Plaque Index Score [1] 
[Units: Score on a scale]
Mean (Standard Deviation)
 3.01  (0.34) 
[1] Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque;1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 millimeter [mm] or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. Plaque Index was calculated by taking average of scores over all tooth sites for a participant.


  Outcome Measures

1.  Primary:   Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration   [ Time Frame: Day 4 post treatment administration ]

2.  Secondary:   Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration   [ Time Frame: Day 4 post treatment administration ]

3.  Secondary:   Plaque Index After 24 Hours of Treatment Administration   [ Time Frame: Day 1 post treatment administration ]

4.  Secondary:   Interproximal Plaque Index After Day 4 of Treatment Administration   [ Time Frame: Day 4 post treatment administration ]

5.  Secondary:   Interproximal Plaque Index After 24 Hours of Treatment Administration   [ Time Frame: Day 1 post treatment administration ]


  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 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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01122862     History of Changes
Other Study ID Numbers: Z36420889
First Submitted: May 11, 2010
First Posted: May 13, 2010
Results First Submitted: May 23, 2013
Results First Posted: July 30, 2013
Last Update Posted: September 9, 2013