Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
NCT ID: NCT02487186
Last Updated: 2016-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2010-03-31
2015-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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%.
Doxicicline
Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
Full-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.
Control group: DB alone
Control group: DB alone (Full-mouth debridment)
Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.
Full-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.
Interventions
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Doxicicline
Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
Full-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 taken medications known to interfere with periodontal health and healing 6 months prior to the study;
* Pregnants or lactants;
* Smokers;
* Sensitive to doxycycline.
35 Years
60 Years
ALL
No
Sponsors
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University of Campinas, Brazil
OTHER
Responsible Party
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Enilson Antonio Sallum
Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil
Principal Investigators
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Enilson A Sallum, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Campinas, Brazil
Locations
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Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil
Countries
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Other Identifiers
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012/2009
Identifier Type: -
Identifier Source: org_study_id