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

Colgate-Palmolive logo

Colgate-Palmolive

Status and phase

Completed
Phase 3

Conditions

Mucositis

Treatments

Drug: Triclosan and Fluoride
Drug: Fluoride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01072201
CRO-0107-PERIO-MUC-ITA-PC

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

Total toothpaste
Experimental group
Description:
Triclosan/copolymer/fluoride toothpaste
Treatment:
Drug: Triclosan and Fluoride
Ultrabrite toothpaste
Placebo Comparator group
Description:
Fluoride Toothpaste
Treatment:
Drug: Fluoride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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