Alternative Antibiotic Regime in the Treatment of GAgP

NCT02223702 | Completed Phase 4 Results

• 1 other identifier: KOUKAEK5/9
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Aggressive Periodontitis; Aggressive Periodontitis

Keywords

Aggressive periodontitis; amoxicillin; metronidazole; moxifloxacin; nonsurgical periodontal debridement.

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Variable Was Probing Depth.

  We measured the probing depth at baseline, 1st, 3rd and 6th months. The changes were evaluated among and between groups.

  6-months

Secondary Outcomes (1)

• The Attachment Loss Were Considered as a Secondary Measure.

  6-months

Study Arms (2)

amoxicillin+metronidazole

ACTIVE COMPARATOR

amoxicillin+metronidazole group received a combination of 500 mg of amoxicillin and 500 mg metronidazole three times per day for 7 days.

Drug: Amoxicillin; Drug: Metronidazole

moxifloxacin

EXPERIMENTAL

The moxifloxacin group received 400 mg moxifloxacin, once in a day for 7 days.

Drug: Moxifloxacin

Interventions

Amoxicillin DRUG

500 mg, 3 times per day for 7 days

Also known as: largopen

amoxicillin+metronidazole

Metronidazole DRUG

500 mg, 3 times per day, for 7 days

Also known as: flagyl

amoxicillin+metronidazole

Moxifloxacin DRUG

400 mg, once in a day for 7 days.

Also known as: pitoxil

moxifloxacin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Faculty of Dentistry Department of Periodontology

Kocaeli, 41190, Turkey (Türkiye)

Location

Related Publications (8)

• Guentsch A, Jentsch H, Pfister W, Hoffmann T, Eick S. Moxifloxacin as an adjunctive antibiotic in the treatment of severe chronic periodontitis. J Periodontol. 2008 Oct;79(10):1894-903. doi: 10.1902/jop.2008.070493.

  PMID: 18834244 BACKGROUND

• Sobottka I, Cachovan G, Sturenburg E, Ahlers MO, Laufs R, Platzer U, Mack D. In vitro activity of moxifloxacin against bacteria isolated from odontogenic abscesses. Antimicrob Agents Chemother. 2002 Dec;46(12):4019-21. doi: 10.1128/AAC.46.12.4019-4021.2002.

  PMID: 12435716 BACKGROUND

• Herrera D, Sanz M, Jepsen S, Needleman I, Roldan S. A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients. J Clin Periodontol. 2002;29 Suppl 3:136-59; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.8.x.

  PMID: 12787214 RESULT

• Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.

  PMID: 20447259 RESULT

• Sgolastra F, Petrucci A, Gatto R, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as an adjunctive therapy to full-mouth scaling and root planing in the treatment of aggressive periodontitis: a systematic review and meta-analysis. J Periodontol. 2012 Jun;83(6):731-43. doi: 10.1902/jop.2011.110432. Epub 2011 Nov 3.

  PMID: 22050545 RESULT

• Herrera D, Alonso B, Leon R, Roldan S, Sanz M. Antimicrobial therapy in periodontitis: the use of systemic antimicrobials against the subgingival biofilm. J Clin Periodontol. 2008 Sep;35(8 Suppl):45-66. doi: 10.1111/j.1600-051X.2008.01260.x.

  PMID: 18724841 RESULT

• Xajigeorgiou C, Sakellari D, Slini T, Baka A, Konstantinidis A. Clinical and microbiological effects of different antimicrobials on generalized aggressive periodontitis. J Clin Periodontol. 2006 Apr;33(4):254-64. doi: 10.1111/j.1600-051X.2006.00905.x.

  PMID: 16553634 RESULT

• Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.

  PMID: 33197289 DERIVED

MeSH Terms

Conditions

Aggressive Periodontitis

Interventions

Amoxicillin; Metronidazole; Moxifloxacin

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Results Point of Contact

• Title: Chair and Associate Professor of Periodontology
• Organization: Kocaeli University

esragd@yahoo.com

+902623442222

Study Officials

• Esra Guzeldemir-Akcakanat

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 22, 2014
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2014
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-02

Locations

TU (1)