To Access the Effects of Mucositis in Adults With Dental Implants

NCT01072201 | Completed Phase 3 Results

• 1 other identifier: CRO-0107-PERIO-MUC-ITA-PC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mucositis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Total toothpaste

EXPERIMENTAL

Triclosan/copolymer/fluoride toothpaste

Drug: Triclosan and Fluoride

Ultrabrite toothpaste

PLACEBO COMPARATOR

Fluoride Toothpaste

Drug: Fluoride

Interventions

Triclosan and Fluoride DRUG

Brush twice daily

Also known as: Total Toothpaste

Total toothpaste

Fluoride DRUG

Brush twice daily

Also known as: Ultrabrite toothpaste

Ultrabrite toothpaste

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Ariminum Research & Dental Education Center

Rimini, Italy

Location

MeSH Terms

Conditions

Mucositis

Interventions

Triclosan; Fluorides; hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Results Point of Contact

• Title: William De Vizio, DMD
• Organization: Colgate Palmolive Co

William_Devizio@colpal.com

732-878-7901

Study Officials

• Per Ramberg, DDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: February 19, 2010
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: October 5, 2010
• Results First Posted: February 19, 2010

Record last verified: 2010-09

Locations

IT (1)