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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01072201 |
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Date of registration:
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26/09/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To Access the Effects of Mucositis in Adults With Dental Implants
implantitis |
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Scientific title:
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To Access the Effects of Mucositis in Adults With Dental Implants |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01072201 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Per Ramberg, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion 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.
Age minimum:
30 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Mucositis
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Intervention(s)
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Drug: Triclosan and Fluoride
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Drug: Fluoride
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Primary Outcome(s)
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Bleeding on Probing
[Time Frame: 6 months]
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Mean Percentage of Plaque Scores
[Time Frame: 6 Months]
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Mean Pocket Depth
[Time Frame: 6 Months]
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Secondary ID(s)
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CRO-0107-PERIO-MUC-ITA-PC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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