Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

University of Campinas, Brazil30 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontal Disease

Interventions

DoxiciclineDRUG

Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.

Full-mouth debridmentPROCEDURE

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic generalized periodontitis (AAP,1999); * At least 7 sites with probing depths \>5mm, and 2 sites with probing depth \>7mm; * At least 20 teeth present; * Systemically healthy. Exclusion Criteria: * Had received periodontal care 6 months prior to the study; * Had taken medications known to interfere with periodontal health and healing 6 months prior to the study; * Pregnants or lactants; * Smokers; * Sensitive to doxycycline.

Locations (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, Brazil

Outcomes

Primary Outcomes

Probing depht (PD)

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

Secondary Outcomes

Clinical attachment level (CAL)

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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