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Alternative Antibiotic Regime in the Treatment of GAgP

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ClinicalTrials.gov Identifier: NCT02223702
Recruitment Status : Completed
First Posted : August 22, 2014
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Esra Guzeldemir-Akcakanat, Kocaeli University

Brief Summary:

The objective of this randomized clinical study was to evaluate the effect of systemic administration of moxifloxacin compared to amoxicillin plus metronidazole combined with non-surgical treatment in patients with generalized aggressive periodontitis (GAgP) in 6-month follow-up.

A total of 40 systemically healthy patients with GAgP will evaluate in this randomized clinical trial. Periodontal parameters (plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level) will be recorded at baseline, 1st, 3rd and 6th month. Patients will receive either 400 mg moxifloxacin per os once daily or 500 mg metronidazole and 500 mg amoxicillin per os three times daily for 7 days consecutively.


Condition or disease Intervention/treatment Phase
Generalized Aggressive Periodontitis Aggressive Periodontitis Drug: Amoxicillin Drug: Metronidazole Drug: Moxifloxacin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of Systemic Moxifloxacin Compared to Amoxicillin Plus Metronidazole Adjunct to Non-surgical Treatment in Generalized Aggressive Periodontitis: A Randomized Clinical Trial
Study Start Date : May 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2014


Arm Intervention/treatment
Active Comparator: amoxicillin+metronidazole
amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days.
Drug: Amoxicillin
500 mg, 3 times per day for 7 days
Other Name: largopen

Drug: Metronidazole
500 mg, 3 times per day, for 7 days
Other Name: flagyl

Experimental: moxifloxacin
The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days.
Drug: Moxifloxacin
400 mg, once in a day for 7 days.
Other Name: pitoxil




Primary Outcome Measures :
  1. The Primary Outcome Variable Was Probing Depth. [ Time Frame: 6-months ]
    We measured the probing depth at baseline, 1st, 3rd and 6th months. The changes were evaluated among and between groups.


Secondary Outcome Measures :
  1. The Attachment Loss Were Considered as a Secondary Measure. [ Time Frame: 6-months ]
    Attachment loss were recorded at baseline, 1st, 3rd and 6th months as millimeters. The data were compared among and between groups.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223702


Locations
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Turkey
Kocaeli University Faculty of Dentistry Department of Periodontology
Kocaeli, Turkey, 41190
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Esra Guzeldemir-Akcakanat Kocaeli University

Publications of Results:
Other Publications:
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Responsible Party: Esra Guzeldemir-Akcakanat, Associate Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT02223702     History of Changes
Other Study ID Numbers: KOUKAEK5/9
First Posted: August 22, 2014    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: February 2018

Keywords provided by Esra Guzeldemir-Akcakanat, Kocaeli University:
Aggressive periodontitis
amoxicillin
metronidazole
moxifloxacin
nonsurgical periodontal debridement.

Additional relevant MeSH terms:
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Periodontitis
Aggression
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms
Amoxicillin
Moxifloxacin
Metronidazole
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents