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

• Sponsor: Colgate Palmolive (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01072201
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

Clinical research for the treatment of mucositis subjects who have dental implants for a minimum of one-year.

Condition or Disease	Intervention/Treatment	Phase
Mucositis	Drug: Triclosan and Fluoride; Drug: Fluoride	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: To Access the Effects of Mucositis in Adults With Dental Implants
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Total toothpaste Triclosan/copolymer/fluoride toothpaste	Drug: Triclosan and Fluoride; Brush twice daily; Other Names: Total Toothpaste
Placebo Comparator: Ultrabrite toothpaste Fluoride Toothpaste	Drug: Fluoride; Brush twice daily; Other Names: Ultrabrite toothpaste

Outcome Measures

Primary Outcome Measures

1. Bleeding on Probing [6 months]

   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.

2. Mean Pocket Depth [6 Months]

   Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.

3. Mean Percentage of Plaque Scores [6 Months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male and female subjects, ages 30-70.

• Availability for the six-month duration of the clinical research study.

• Good general health.

• Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.

• Minimum of 5 remaining teeth and a minimum of 2 implants.

• Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing.

• Initial plaque evaluation by determining full mouth presence/absence of plaque.

• Signed Informed Consent Form.

Exclusion Criteria:

• Tumor(s) of the soft or hard tissues of the oral cavity.

• Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).

• Carious lesions requiring immediate restorative treatment.

• Uncontrolled Diabetes

• Use of antibiotics any time during the one month prior to entry into the study.

• Untreated peri-implantitis.

• Participation in any other clinical research study or test panel within the three months prior to entry into the study.

• Pregnant women or women who are breast feeding.

• History of allergies to personal care/consumer products or their ingredients.

• Medical condition which prohibits not eating/drinking for up to 2 hours.

• Current alcohol or drug abuse.

• Systemic or local disease conditions that would compromise post-operative healing.

• Regular use of anti-inflammatory drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ariminum Research & Dental Education Center	Rimini		Italy

Sponsors and Collaborators

• Colgate Palmolive

Investigators

• Principal Investigator: Per Ramberg, DDS,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01072201
• Other Study ID Numbers: CRO-0107-PERIO-MUC-ITA-PC
• First Posted: Feb 19, 2010
• Last Update Posted: Oct 5, 2010
• Last Verified: Sep 1, 2010

• Additional relevant MeSH terms: Mucositis; Triclosan; Fluorides

Study Results

Participant Flow

Arm/Group Title	Total Toothpaste	Ultrabrite Toothpaste
Arm/Group Description	Triclosan/copolymer/Fluoride	sodium fluoride control(placebo)
Period Title: Overall Study
STARTED	30	30
COMPLETED	30	29
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Total Toothpaste	Ultrabrite Toothpaste	Total
Arm/Group Description	Triclosan/copolymer/Fluoride	sodium fluoride control (placebo)	Total of all reporting groups
Overall Participants	30	30	60
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.36 (7.38)	57.83 (7.97)	57.59 (7.61)
Sex: Female, Male (Count of Participants)
Female	20 66.7%	21 70%	41 68.3%
Male	10 33.3%	9 30%	19 31.7%
Region of Enrollment (participants) [Number]
Italy	30 100%	30 100%	60 100%

Outcome Measures

1. Primary Outcome

Title	Bleeding on Probing
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Toothpaste	Ultrabrite Toothpaste
Arm/Group Description	Triclosan/copolymer/Fluoride	sodium fluoride control (placebo)
Measure Participants	30	29
Mean (Standard Deviation) [Percentage of bleeding sites]	53.8 (17.6)	52.3 (24.6)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Toothpaste	Ultrabrite Toothpaste
Arm/Group Description	Triclosan/copolymer/Fluoride	sodium fluoride control (placebo)
Measure Participants	30	29
Mean (Standard Deviation) [Millimeters]	4.4 (0.6)	4.5 (0.5)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

3. Primary Outcome

Title	Mean Percentage of Plaque Scores
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Total Toothpaste	Ultrabrite Toothpaste
Arm/Group Description	Triclosan/copolymer/Fluoride	sodium fluoride control (placebo)
Measure Participants	30	29
Mean (Standard Deviation) [percentage of dental plaque]	13.2 (15.6)	16.0 (17.8)

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
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Arm/Group Title	Total Toothpaste		Ultrabrite Toothpaste
Arm/Group Description	Triclosan/copolymer/Fluoride		sodium fluoride control (placebo)
All Cause Mortality
	Total Toothpaste		Ultrabrite Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Total Toothpaste		Ultrabrite Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Total Toothpaste		Ultrabrite Toothpaste
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.