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Trial record 15 of 43 for:    FLUORIDE ION AND TRICLOSAN

To Access the Effects of Mucositis in Adults With Dental Implants (implantitis)

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: NCT01072201
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : February 19, 2010
Last Update Posted : October 5, 2010
Sponsor:
Information provided by:
Colgate Palmolive

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Mucositis
Interventions Drug: Triclosan and Fluoride
Drug: Fluoride
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Total Toothpaste Ultrabrite Toothpaste
Hide Arm/Group Description Triclosan/copolymer/Fluoride sodium fluoride control(placebo)
Period Title: Overall Study
Started 30 30
Completed 30 29
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Total Toothpaste Ultrabrite Toothpaste Total
Hide Arm/Group Description Triclosan/copolymer/Fluoride sodium fluoride control (placebo) 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
26
  86.7%
26
  86.7%
52
  86.7%
>=65 years
4
  13.3%
4
  13.3%
8
  13.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
57.36  (7.38) 57.83  (7.97) 57.59  (7.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
20
  66.7%
21
  70.0%
41
  68.3%
Male
10
  33.3%
9
  30.0%
19
  31.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Bleeding on Probing
Hide Description Percentage of Bleeding Scale: The bleeding sites are identified by either a 0 or 1. (0=no bleeding & 1= bleeding) The number of spots between teeth that bleed are divided by number of spots between teeth that are scored.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Ultrabrite Toothpaste
Hide Arm/Group Description:
Triclosan/copolymer/Fluoride
sodium fluoride control (placebo)
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Percentage of bleeding sites
53.8  (17.6) 52.3  (24.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Ultrabrite Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Mean Pocket Depth
Hide Description Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Ultrabrite Toothpaste
Hide Arm/Group Description:
Triclosan/copolymer/Fluoride
sodium fluoride control (placebo)
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: Millimeters
4.4  (0.6) 4.5  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Ultrabrite Toothpaste
Comments The null hypothesis states that there is no difference between groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Mean Percentage of Plaque Scores
Hide Description Mean Percentage (%) of dental plaque on all tooth surfaces, including implants and natural teeth. Plaque Scale is 0=no plaque and 1= dental plaque present. Percentage is derived from sum of all plaque scores divided by the number of tooth surfaces scored.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Total Toothpaste Ultrabrite Toothpaste
Hide Arm/Group Description:
Triclosan/copolymer/Fluoride
sodium fluoride control (placebo)
Overall Number of Participants Analyzed 30 29
Mean (Standard Deviation)
Unit of Measure: percentage of dental plaque
13.2  (15.6) 16.0  (17.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Total Toothpaste, Ultrabrite Toothpaste
Comments The null hypothesis states that there is no difference between groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Total Toothpaste Ultrabrite Toothpaste
Hide Arm/Group Description Triclosan/copolymer/Fluoride sodium fluoride control (placebo)
All-Cause Mortality
Total Toothpaste Ultrabrite Toothpaste
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total Toothpaste Ultrabrite Toothpaste
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total Toothpaste Ultrabrite Toothpaste
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/29 (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: William De Vizio, DMD
Organization: Colgate Palmolive Co
Phone: 732-878-7901
EMail: William_Devizio@colpal.com
Layout table for additonal information
Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT01072201     History of Changes
Other Study ID Numbers: CRO-0107-PERIO-MUC-ITA-PC
First Submitted: September 26, 2008
First Posted: February 19, 2010
Results First Submitted: September 26, 2008
Results First Posted: February 19, 2010
Last Update Posted: October 5, 2010