NCT02487186

Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Periodontal Disease

Interventions

Type	Name	Description
DRUG	Doxicicline	Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
PROCEDURE	Full-mouth debridment	The patients will be treated by a single-session of periodontal debridement during 45 minutes, using an ultrasonic instrument (Cavitron, Dentsply, Rio de Janeiro, Brazil), under irrigation with sterile saline solution 20. After the debridement, local administration of microspheres loading doxycycline (DOX) (test) or empty microspheres (control) was performed.

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2015-07-01
• Last updated: 2016-03-31

Locations

1 site across 1 country: Brazil