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

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

Study Overview

• Status: Completed
• Conditions: Mucositis
• Intervention / Treatment: Drug: Fluoride; Drug: Triclosan and Fluoride

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Rimini, Italy
    • Ariminum Research & Dental Education Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Per Ramberg, DDS

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 19, 2010

Study Record Updates

• Last Update Posted (Estimate): October 5, 2010
• Last Update Submitted That Met QC Criteria: September 29, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Protective Agents; Hypolipidemic Agents; Lipid Regulating Agents; Cariostatic Agents; Fatty Acid Synthesis Inhibitors; Fluorides; Triclosan
• Other Study ID Numbers: CRO-0107-PERIO-MUC-ITA-PC