Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE June 26, 2015
First Posted Date  ICMJE July 1, 2015
Last Update Posted Date March 31, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02487186 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
Official Title  ICMJE Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Periodontal Disease
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • 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%.
    Interventions:
    • Drug: Doxicicline
    • Procedure: Full-mouth debridment
  • 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.

    Intervention: Procedure: Full-mouth debridment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2015)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02487186
Other Study ID Numbers  ICMJE 012/2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Enilson Antonio Sallum, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Enilson A Sallum, PhD University of Campinas, Brazil
PRS Account University of Campinas, Brazil
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP