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Phase 4 Completed N=39 Randomized Double-blind Supportive Care

Alternative Antibiotic Regime in the Treatment of GAgP

Generalized Aggressive Periodontitis · Aggressive Periodontitis
Source: ClinicalTrials.gov NCT02223702 ↗
Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: The Primary Outcome Variable Was Probing Depth. — 4.57; 4.18; 3.12; 2.91 mm — p=<0.01
◆ Published Evidence
Highly cited
462citations · ~19 / year
A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients.
Journal of clinical periodontology · 2002 · High-confidence link

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.

Linked Publications (5)

  • A systematic review on the effect of systemic antimicrobials as an adjunct to scaling and root planing in periodontitis patients.
    Journal of clinical periodontology · 2002 · 462 citations · High-confidence link
  • Antimicrobial therapy in periodontitis: the use of systemic antimicrobials against the subgingival biofilm.
    Journal of clinical periodontology · 2008 · 340 citations · High-confidence link
  • 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.
    Journal of clinical periodontology · 2010 · 173 citations · High-confidence link
  • Clinical and microbiological effects of different antimicrobials on generalized aggressive periodontitis.
    Journal of clinical periodontology · 2006 · 168 citations · High-confidence link
  • 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.
    Journal of periodontology · 2012 · 141 citations · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
The Primary Outcome Variable Was Probing Depth.
4.57; 4.18; 3.12; 2.91; 3.11; 2.79 <0.01 sig
SECONDARY
The Attachment Loss Were Considered as a Secondary Measure.
5.03; 4.94; 4.37; 4.14; 4.41; 3.98 <0.01 sig

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02223702) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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