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

September 26, 2008
September 29, 2010
June 2007
December 2007   (final data collection date for primary outcome measure)
  • Bleeding on Probing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.
  • Mean Percentage of Plaque Scores [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.
  • Bleeding on Probing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean Pocket Depth [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Mean Percentage of Plaque Scores [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01072201 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
To Access the Effects of Mucositis in Adults With Dental Implants
To Access the Effects of Mucositis in Adults With Dental Implants

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Mucositis
  • Drug: Triclosan and Fluoride
    Brush twice daily
    Other Name: Total Toothpaste
  • Drug: Fluoride
    Brush twice daily
    Other Name: Ultrabrite toothpaste
  • Experimental: Total toothpaste
    Triclosan/copolymer/fluoride toothpaste
    Intervention: Drug: Triclosan and Fluoride
  • Placebo Comparator: Ultrabrite toothpaste
    Fluoride Toothpaste
    Intervention: Drug: Fluoride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01072201
CRO-0107-PERIO-MUC-ITA-PC
No
William DeVizio/VP - Clinical Research, Colgate Palmolive
Colgate Palmolive
Not Provided
Principal Investigator: Per Ramberg, DDS
Colgate Palmolive
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP