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Trial Outcomes & Findings for To Access the Effects of Mucositis in Adults With Dental Implants (NCT NCT01072201)

NCT ID: NCT01072201

Last Updated: 2010-10-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

6 months

Results posted on

2010-10-05

Participant Flow

Participant milestones

Participant milestones
Measure
Total Toothpaste
Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste
sodium fluoride control(placebo)
Overall Study
STARTED
30
30
Overall Study
COMPLETED
30
29
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Total Toothpaste
Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste
sodium fluoride control(placebo)
Overall Study
Lost to Follow-up
0
1

Baseline Characteristics

To Access the Effects of Mucositis in Adults With Dental Implants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Total Toothpaste
n=30 Participants
Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste
n=30 Participants
sodium fluoride control (placebo)
Total
n=60 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
26 Participants
n=5 Participants
26 Participants
n=7 Participants
52 Participants
n=5 Participants
Age, Categorical
>=65 years
4 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
Age Continuous
57.36 years
STANDARD_DEVIATION 7.38 • n=5 Participants
57.83 years
STANDARD_DEVIATION 7.97 • n=7 Participants
57.59 years
STANDARD_DEVIATION 7.61 • n=5 Participants
Sex: Female, Male
Female
20 Participants
n=5 Participants
21 Participants
n=7 Participants
41 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
9 Participants
n=7 Participants
19 Participants
n=5 Participants
Region of Enrollment
Italy
30 participants
n=5 Participants
30 participants
n=7 Participants
60 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Total Toothpaste
n=30 Participants
Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste
n=29 Participants
sodium fluoride control (placebo)
Bleeding on Probing
53.8 Percentage of bleeding sites
Standard Deviation 17.6
52.3 Percentage of bleeding sites
Standard Deviation 24.6

PRIMARY outcome

Timeframe: 6 Months

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

Outcome measures

Outcome measures
Measure
Total Toothpaste
n=30 Participants
Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste
n=29 Participants
sodium fluoride control (placebo)
Mean Pocket Depth
4.4 Millimeters
Standard Deviation 0.6
4.5 Millimeters
Standard Deviation 0.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Total Toothpaste
n=30 Participants
Triclosan/copolymer/Fluoride
Ultrabrite Toothpaste
n=29 Participants
sodium fluoride control (placebo)
Mean Percentage of Plaque Scores
13.2 percentage of dental plaque
Standard Deviation 15.6
16.0 percentage of dental plaque
Standard Deviation 17.8

Adverse Events

Total Toothpaste

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ultrabrite Toothpaste

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William De Vizio, DMD

Colgate Palmolive Co

Phone: 732-878-7901

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60