Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, 13414-903, Brazil
NCT Number: NCT02487186
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.
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Notify Me35 year–60 year
All sexes
Interventional
Phase 4
Piracicaba, São Paulo, 13414-903, Brazil
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
Other names: PLGA microspheres
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.
Time frame: 6 months
Probing depth (PD) will be measured at six sites per tooth by a PCP-15 periodontal Probe (Hu-Friedy - Chicago, IL, USA); This measure will be performed with the use of a plastic stent, presenting edges for the positioning of the stent probe.
Time frame: 6 months
Six sites per tooth, will be measured with a PCP-15 Periodontal Probe (Hu-Friedy - Chicago, IL, USA). This measure will be performed with the use of a plastic stent, presenting edges for the positioning of the stent probe.
University of Campinas, Brazil
Other
Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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