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Completed

NCT Number: NCT02487186

Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

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.

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Key information

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxicicline

Drug

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

Other names: PLGA microspheres

Full-mouth debridment

Procedure

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.

Primary outcomes

  1. 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

  1. Clinical attachment level (CAL)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jul 1, 2015
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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