To Access the Effects of Mucositis in Adults With Dental Implants

NCT ID: NCT01072201

Last Updated: 2010-10-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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Conditions

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Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Total toothpaste

Triclosan/copolymer/fluoride toothpaste

Group Type EXPERIMENTAL

Triclosan and Fluoride

Intervention Type DRUG

Brush twice daily

Ultrabrite toothpaste

Fluoride Toothpaste

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

Brush twice daily

Interventions

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Triclosan and Fluoride

Brush twice daily

Intervention Type DRUG

Fluoride

Brush twice daily

Intervention Type DRUG

Other Intervention Names

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Total Toothpaste Ultrabrite toothpaste

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Colgate Palmolive

Principal Investigators

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Per Ramberg, DDS

Role: PRINCIPAL_INVESTIGATOR

Locations

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Ariminum Research & Dental Education Center

Rimini, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CRO-0107-PERIO-MUC-ITA-PC

Identifier Type: -

Identifier Source: org_study_id