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

Primary Purpose

Mucositis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Triclosan and Fluoride
Fluoride
Sponsored by
Colgate Palmolive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ariminum Research & Dental Education Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Total toothpaste

Ultrabrite toothpaste

Arm Description

Triclosan/copolymer/fluoride toothpaste

Fluoride Toothpaste

Outcomes

Primary Outcome Measures

Bleeding on Probing
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.
Mean Pocket Depth
Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.
Mean Percentage of Plaque Scores
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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2008
Last Updated
September 29, 2010
Sponsor
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT01072201
Brief Title
To Access the Effects of Mucositis in Adults With Dental Implants
Acronym
implantitis
Official Title
To Access the Effects of Mucositis in Adults With Dental Implants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Colgate Palmolive

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Total toothpaste
Arm Type
Experimental
Arm Description
Triclosan/copolymer/fluoride toothpaste
Arm Title
Ultrabrite toothpaste
Arm Type
Placebo Comparator
Arm Description
Fluoride Toothpaste
Intervention Type
Drug
Intervention Name(s)
Triclosan and Fluoride
Other Intervention Name(s)
Total Toothpaste
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Fluoride
Other Intervention Name(s)
Ultrabrite toothpaste
Intervention Description
Brush twice daily
Primary Outcome Measure Information:
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Ramberg, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ariminum Research & Dental Education Center
City
Rimini
Country
Italy

12. IPD Sharing Statement

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To Access the Effects of Mucositis in Adults With Dental Implants

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