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Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

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ClinicalTrials.gov Identifier: NCT02487186
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Enilson Antonio Sallum, 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.

Condition or disease Intervention/treatment Phase
Periodontal Disease Drug: Doxicicline Procedure: Full-mouth debridment Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
Study Start Date : March 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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%.
Drug: Doxicicline
Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
Other Name: PLGA microspheres

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.


Active Comparator: Control group: DB alone

Control group: DB alone (Full-mouth debridment)

Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.

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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02487186


Locations
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Brazil
Piracicaba Dental School, State University of Campinas
Piracicaba, São Paulo, Brazil, 13414-903
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
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Principal Investigator: Enilson A Sallum, PhD University of Campinas, Brazil

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Responsible Party: Enilson Antonio Sallum, Professor, department of Periodontics, Piracicaba Dental School, State University of Campinas (UNICAMP), Piracicaba, São Paulo, Brazil, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02487186     History of Changes
Other Study ID Numbers: 012/2009
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Enilson Antonio Sallum, University of Campinas, Brazil:
Chronic periodontitis
Local doxycycline
Ultrasonic debridement
PLGA microspheres
Microbiologic assessment

Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents