Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

Periodontal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487186
• Other study ID #: 012/2009
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2015
• Last updated: March 30, 2016
• Start date: March 2010
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Drug:
• Doxicicline
Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.

Procedure:
• 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.

Locations

Country	Name	City	State
Brazil	Piracicaba Dental School, State University of Campinas	Piracicaba	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No