Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
Overview
- Phase
- Phase 4
- Intervention
- Doxicicline
- Conditions
- Periodontal Disease
- Sponsor
- University of Campinas, Brazil
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Probing depht (PD)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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).
Investigators
Enilson Antonio Sallum
Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil
University of Campinas, Brazil
Eligibility Criteria
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;
- •Sensitive to doxycycline.
Arms & Interventions
Test group: DB+DOX
Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%.
Intervention: Doxicicline
Test group: DB+DOX
Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%.
Intervention: Full-mouth debridment
Control group: DB alone
Control group: DB alone (Full-mouth debridment) Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.
Intervention: Full-mouth debridment
Outcomes
Primary Outcomes
Probing depht (PD)
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.
Secondary Outcomes
- Clinical attachment level (CAL)(6 months)