Periodontal Disease
Conditions
Keywords
Chronic periodontitis, Local doxycycline, Ultrasonic debridement, PLGA microspheres, Microbiologic assessment
Brief 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).
Interventions
DRUGDoxicicline
Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
PROCEDUREFull-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.
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing depht (PD) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level (CAL) | 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. |
Countries
Brazil
Outcome results
None listed