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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group: DB+DOX | Active Comparator | Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%. |
|
| Control group: DB alone | Active Comparator | Control group: DB alone (Full-mouth debridment) Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxicicline | Drug | Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enilson A Sallum, PhD | University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piracicaba Dental School, State University of Campinas | Piracicaba | São Paulo | 13414-903 | Brazil |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010518 | Periodontitis |
| D002908 | Chronic Disease |
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| Full-mouth debridment | Procedure | 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. |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |