Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Periodontal Disease

Intervention / Treatment
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* Drug: Doxicicline
* Procedure: Full-mouth debridment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test group: DB+DOX<br>Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%. | Drug: Doxicicline<br>* Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.<br>* Other names: PLGA microspheres;Procedure: Full-mouth debridment<br>* 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.<br>|
| Active Comparator: Control group: DB alone<br>Control group: DB alone (Full-mouth debridment) Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres. | Procedure: Full-mouth debridment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic periodontitis, Local doxycycline, Ultrasonic debridement, PLGA microspheres, Microbiologic assessment