Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

Phase 4

Completed

• Conditions: Periodontal Disease
• Interventions: Drug: Doxicicline; Procedure: Full-mouth debridment

• Registration Number: NCT02487186
• Lead Sponsor: University of Campinas, Brazil

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).

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2014-12
• Status Verified: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-27
• Study First Posted: 2015-07-01
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group: DB+DOX	Doxicicline	Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%.
Test group: DB+DOX	Full-mouth debridment	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	Full-mouth debridment	Control group: DB alone (Full-mouth debridment) Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.

Primary Outcome Measures

Name	Time	Method
Probing depht (PD)	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 Outcome Measures

Name	Time	Method
Clinical attachment level (CAL)	6 months	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.

Trial Locations

Locations (1)

Piracicaba Dental School, State University of Campinas; 🇧🇷 Piracicaba, São Paulo, Brazil