Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Periodontal Disease

Treatments: Drug: Doxicicline; Procedure: Full-mouth debridment

Study type: Interventional

Funder types: Other

Identifiers

NCT02487186

012/2009

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Test group: DB+DOX

Active Comparator group

Description:

Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%.

Treatment:

Drug: Doxicicline

Procedure: Full-mouth debridment

Control group: DB alone

Active Comparator group

Description:

Control group: DB alone (Full-mouth debridment) Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.

Treatment:

Procedure: Full-mouth debridment