Clinical Study to Examine Brushing on Dental Implants

NCT ID: NCT00762619

Last Updated: 2011-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-08-31

Brief Summary

The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants

Conditions

Gingival Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A -

fluoride toothpaste (Ultrabrite)

Group Type: PLACEBO_COMPARATOR

Fluoride

Intervention Type: DRUG

Brush twice daily

B - Postive control

fluoride/triclosan/copolymer toothpaste

Group Type: ACTIVE_COMPARATOR

Triclosan, fluoride

Intervention Type: DRUG

Brush twice daily

Interventions

Fluoride

Brush twice daily

Intervention Type: DRUG

Triclosan, fluoride

Brush twice daily

Intervention Type: DRUG

Other Intervention Names

Ultrabrite toothpaste; Total toothpaste

Eligibility Criteria

Inclusion Criteria

• Males and females in good oral and general health aged 18 to 76 years.
• A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate willingness to comply with all study procedures and availability for duration of study.
• Subjects will use the provided test articles and discontinue the use of other dentifrices and mouthrinses for the duration of the study.
• A minimum of 20 natural teeth with facial and lingual scorable surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.
• Adequate oral hygiene and no signs of oral neglect.
• Subjects will have at least one dental implant and a contralateral natural tooth.
• At the first visit subjects will be examined by a dentist for periodontal health.
• Selected subjects will have periodontal pockets less than 6mm.
• Subjects with gingival index equal to or greater than 1.0 and plaque index equal to or greater than or 1. 5 on the implant tooth will be enrolled. Gingival and plaque indices will be measured during the first visit for the implant. Similarly, these clinical indices (Gingival and plaque index) will be determined for the contralateral natural tooth. (The adjacent teeth will serve as a backup for the studies if control tooth is lost during study).
• Subjects who are habitual users of Colgate Total or other oral hygiene formulations with antimicrobial agents will complete a washout phase of 30 days with a commercial fluoride dentifrice prior to enrollment in the study. This washout dentifrice will be identified and obtained by the clinical investigator from an appropriate local source.

Exclusion Criteria

• History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
• Regular use of mouthwash with antimicrobial agents within the past month.
• History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
• History of hepatitis, rheumatic fever, pacemaker, or prosthetic heart valves, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
• Subjects presenting significant medical conditions or need for long term drug therapy.
• Subjects on antibiotic, anti inflammatory or anticoagulant therapy during the month preceding the baseline exam.
• Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations) that would interfere with the study.
• History of active severe periodontal disease with bleeding gums and loose teeth.
• Widespread caries or chronic neglect. Subjects presenting with gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, and large fractured or temporary restorations (based on visual examinations).
• Fixed or removable orthodontic appliance or removable partial dentures.
• Participation in any clinical study including dental plaque/gingivitis clinical trial involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the month preceding the start of study.
• Self reported pregnancy or lactation.
• History or current use of objects to pierce the lips or tongue.
• Subjects known to be an alcoholic, or a recovering alcoholic.
• History or current use of recreational drugs or narcotics.
• Determine smoking status of subjects and exclude current smokers.
• Determine reason for placing implants in subject to exclude subjects whose implants were placed for trauma.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Colgate Palmolive

Principal Investigators

Jonathan Mann, MSc

Role: PRINCIPAL_INVESTIGATOR

Joseph J Zambon, DDS

Role: PRINCIPAL_INVESTIGATOR

Locations

State University of New York at Buffalo

Buffalo, New York, United States

The Hebrew University-Hadassah

Jerusalem, , Israel

Countries

United States; Israel

Other Identifiers

CRO-2007-IMPLANT-PS

Identifier Type: -

Identifier Source: org_study_id