Phase 4 N=39 Randomized Double-blind Supportive Care

Alternative Antibiotic Regime in the Treatment of GAgP

Generalized Aggressive Periodontitis · Aggressive Periodontitis

Bottom Line

View on ClinicalTrials.gov: NCT02223702 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: The Primary Outcome Variable Was Probing Depth. — 4.57; 4.18; 3.12; 2.91 mm — p=<0.01

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Amoxicillin (Drug); Metronidazole (Drug); Moxifloxacin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Kocaeli University
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-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

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.

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). 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.