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OpenTrials
Completed

NCT Number: NCT01072201

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ariminum Research & Dental Education Center

Rimini, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triclosan and fluoride

Drug

Brush twice daily

Other names: Total Toothpaste

Fluoride

Drug

Brush twice daily

Other names: Ultrabrite toothpaste

Primary outcomes

  1. Bleeding on Probing

    Time frame: 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.

  2. Mean Pocket Depth

    Time frame: 6 Months

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

  3. Mean Percentage of Plaque Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Acronym: implantitis

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 19, 2010
Registry last updated
Oct 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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