To Access the Effects of Mucositis in Adults With Dental Implants

Mucositis Clinical Trial

— implantitis  

Official title:

To Access the Effects of Mucositis in Adults With Dental Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072201
• Other study ID #: CRO-0107-PERIO-MUC-ITA-PC
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: September 29, 2010
• Start date: June 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2010
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucositis

Intervention

Drug:
• Triclosan and Fluoride
Brush twice daily
• Fluoride
Brush twice daily

Locations

Country	Name	City	State
Italy	Ariminum Research & Dental Education Center	Rimini

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Mean Pocket Depth	Measurement scale: 0 millimeter measurement= no pocket depth. 3, 4, 5, & 6 millimeter are indications of deeper Pocket depth.	6 Months	No
Primary	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	No