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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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12 December 2020 |
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Main ID: |
NCT02223702 |
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Date of registration:
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20/08/2014 |
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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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Alternative Antibiotic Regime in the Treatment of GAgP
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Scientific title:
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Clinical Evaluation of Systemic Moxifloxacin Compared to Amoxicillin Plus Metronidazole Adjunct to Non-surgical Treatment in Generalized Aggressive Periodontitis: A Randomized Clinical Trial |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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39 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02223702 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Esra Guzeldemir-Akcakanat |
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Address:
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Telephone:
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Email:
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Affiliation:
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Kocaeli University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The periodontal diagnosis of subjects with GAgP was established on the basis of
clinical and radiographic criteria defined by the 1999 International World Workshop
for a Classification of Periodontal Diseases and Conditions.
- Patients were included if they were between 18 and 35 years of age and otherwise
healthy.
Exclusion Criteria:
- if the patients had any known systemic diseases or conditions that can/could influence
the periodontal status (cancer, cardiovascular and respiratory diseases)
- history of hepatitis or HIV infection,
- immunosuppressive chemotherapy
- current pregnancy, planning a pregnancy or lactation
- requirement for antibiotic prophylaxis
- oral diseases other than GAgP, ongoing orthodontic therapy
- a history of antibiotic therapy or periodontal treatment within the preceding six
months.
- Subjects were excluded if they had known allergies to quinolones or penicillin or
metronidazole
- Not willing to participate to the study.
- Not accept to sign written informed consent
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Aggressive Periodontitis
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Generalized Aggressive Periodontitis
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Intervention(s)
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Drug: Amoxicillin
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Drug: Metronidazole
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Drug: Moxifloxacin
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Primary Outcome(s)
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The Primary Outcome Variable Was Probing Depth.
[Time Frame: 6-months]
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Secondary Outcome(s)
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The Attachment Loss Were Considered as a Secondary Measure.
[Time Frame: 6-months]
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Secondary ID(s)
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KOUKAEK5/9
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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