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

This study has been completed.

Sponsor:

Information provided by:

Colgate Palmolive

ClinicalTrials.gov Identifier:

NCT01072201

First received: September 26, 2008

Last updated: September 29, 2010

Last verified: September 2010

History of Changes

Results First Received: September 26, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Mucositis
Interventions:	Drug: Triclosan and Fluoride Drug: Fluoride

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Total Toothpaste	Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste	sodium fluoride control(placebo)

Participant Flow: Overall Study

	Total Toothpaste	Ultrabrite Toothpaste
STARTED	30	30
COMPLETED	30	29
NOT COMPLETED	0	1
Lost to Follow-up	0	1

Baseline Characteristics

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Reporting Groups

	Description
Total Toothpaste	Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste	sodium fluoride control (placebo)
Total	Total of all reporting groups

Baseline Measures

	Total Toothpaste	Ultrabrite Toothpaste	Total
Number of Participants [units: participants]	30	30	60
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	26	26	52
>=65 years	4	4	8
Age [units: years] Mean ± Standard Deviation	57.36 ± 7.38	57.83 ± 7.97	57.59 ± 7.61
Gender [units: participants]
Female	20	21	41
Male	10	9	19
Region of Enrollment [units: participants]
Italy	30	30	60

Outcome Measures

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1. Primary:

Bleeding on Probing [ Time Frame: 6 months ]

Measure Type	Primary
Measure Title	Bleeding on Probing
Measure 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
Safety Issue	No

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/copolymer/Fluoride
Ultrabrite Toothpaste	sodium fluoride control (placebo)

Measured Values

	Total Toothpaste	Ultrabrite Toothpaste
Number of Participants Analyzed [units: participants]	30	29
Bleeding on Probing [units: Percentage of bleeding sites] Mean ± Standard Deviation	53.8 ± 17.6	52.3 ± 24.6

Statistical Analysis 1 for Bleeding on Probing

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis states that there is no difference between groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Primary:

Mean Pocket Depth [ Time Frame: 6 Months ]

Measure Type	Primary
Measure Title	Mean Pocket Depth
Measure Description	Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.
Time Frame	6 Months
Safety Issue	No

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/copolymer/Fluoride
Ultrabrite Toothpaste	sodium fluoride control (placebo)

Measured Values

	Total Toothpaste	Ultrabrite Toothpaste
Number of Participants Analyzed [units: participants]	30	29
Mean Pocket Depth [units: Millimeters] Mean ± Standard Deviation	4.4 ± 0.6	4.5 ± 0.5

Statistical Analysis 1 for Mean Pocket Depth

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis states that there is no difference between groups.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

3. Primary:

Mean Percentage of Plaque Scores [ Time Frame: 6 Months ]

Measure Type	Primary
Measure Title	Mean Percentage of Plaque Scores
Measure 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
Safety Issue	No

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/copolymer/Fluoride
Ultrabrite Toothpaste	sodium fluoride control (placebo)

Measured Values

	Total Toothpaste	Ultrabrite Toothpaste
Number of Participants Analyzed [units: participants]	30	29
Mean Percentage of Plaque Scores [units: percentage of dental plaque] Mean ± Standard Deviation	13.2 ± 15.6	16.0 ± 17.8

Statistical Analysis 1 for Mean Percentage of Plaque Scores

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.05

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	The null hypothesis states that there is no difference between groups
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

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
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Results Point of Contact:

Name/Title: William De Vizio, DMD
Organization: Colgate Palmolive Co
phone: 732-878-7901
e-mail: William_Devizio@colpal.com

No publications provided

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
Study First Received:	September 26, 2008
Results First Received:	September 26, 2008
Last Updated:	September 29, 2010
Health Authority:	United States: Food and Drug Administration

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