Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

Periodontal Disease Clinical Trial

Official title: Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.

Status Completed

Clinical Trial Summary

The aim of this clinical study is to asses the effect of ultrasonic periodontal debridement associated to locally delivered doxycycline (20%) by PLGA microspheres on chronic generalized periodontitis treatment.

Clinical Trial Description

Thirty patients with chronic periodontitis and a minimum of seven pockets (>5

mm) in non-molars teeth that bled on probing will be selected. Patients will be randomly

assigned to ultrasonic periodontal debridement followed by local application of doxycycline

by PLGA microspheres (DB+DOX) and periodontal debridement followed by administration

of void PLGA microspheres (DB). Plaque, bleeding on probe, clinical attachment level

(CAL), and probing depth (PD) will be recorded at baseline, 3 and 6 months. Subgingival

biofilm samples will be collected from initially moderate (5 to 6 mm) and deep (≥7 mm)

pockets at baseline, 1, 3 and 6 months. Polimerase chain reaction (PCR) analysis will be

used to detect the frequency of Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf),

Treponema denticola (Td), Aggregatibacter actinomycetemcomitans (Aa), and Prevotella

intermedia (Pi). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

• NCT number: NCT02487186
• Study type: Interventional
• Source: University of Campinas, Brazil
• Status: Completed
• Phase: Phase 4
• Start date: March 2010
• Completion date: June 2015