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Efficacy of Three Antibiotic Protocols for Aggressive Periodontitis Treatment

Efficacy of Moxifloxacin, Amoxicillin+Metronidazole for Aggressive Periodontitis Treatment

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02839421
Enrollment
36
Registered
2016-07-21
Start date
2015-12-31
Completion date
2019-05-31
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive Periodontitis

Brief summary

The aim of the present study is to evaluate the clinical and microbiological efficacy of moxifloxacin or amoxicillin plus metronidazole in one-stage scaling and root planing in treating generalized aggressive periodontitis. Forty five subjects will be randomly allocated to 3 treatment groups. Subgingival plaque samples will be analysed for cultivable bacteria. The primary outcome variable to determine the superiority of one treatment over the others would be differences between groups for means CAL changes at 6 months post-treatment. Secondary outcome variables include differences between therapies for the mean changes in the mean levels of PD and the proportion of BOP.

Interventions

DRUGScaling and Root Planing combined with moxifloxacin

Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days

Sponsors

Facultad Nacional de Salud Publica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Subjects ≤30 years of age * minimum of six permanent teeth, with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and a minimum of six teeth other than first molars and incisors with at least one site each with PD and CAL ≥5 mm.

Exclusion criteria

* diabetes * cardiovascular diseases * immunological disorders or any other systemic disease that could alter the course of periodontal disease. * Pregnant or nursing women * smoking * allergy to amoxicillin, metronidazole, fluoroquinolones or moxifloxacin * consumption of systemic antimicrobials or anti-inflammatory drugs in the last 6 months * periodontal therapy during the last 6 months

Design outcomes

Primary

MeasureTime frameDescription
clinical attachment level3 and 6 monthsIt was defined that the primary outcome variable to determine the superiority of one treatment over the other would be differences between groups for means Clinical Attachment Level changes at 6 months post-treatment. This is a measure assessing change between two time points .

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026