Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
Primary Purpose
Periodontal Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Doxicicline
Full-mouth debridment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease focused on measuring Chronic periodontitis, Local doxycycline, Ultrasonic debridement, PLGA microspheres, Microbiologic assessment
Eligibility 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.
Sites / Locations
- Piracicaba Dental School, State University of Campinas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test group: DB+DOX
Control group: DB alone
Arm Description
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) Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.
Outcomes
Primary Outcome Measures
Probing depht (PD)
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
Clinical attachment level (CAL)
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.
Full Information
NCT ID
NCT02487186
First Posted
June 26, 2015
Last Updated
March 30, 2016
Sponsor
University of Campinas, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT02487186
Brief Title
Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
Official Title
Evaluation of PLGA Microspheres Loaded With Doxycycline Associated to Periodontal Debridement in the Treatment of Chronic Advanced Periodontitis.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
Chronic periodontitis, Local doxycycline, Ultrasonic debridement, PLGA microspheres, Microbiologic assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group: DB+DOX
Arm Type
Active Comparator
Arm Description
Test group: DB (full mouth debridment) +DOX (doxicicline) - 45 minutes of full-mouth debridement + subgingival application of PLGA microspheres loading doxycycline 10%.
Arm Title
Control group: DB alone
Arm Type
Active Comparator
Arm Description
Control group: DB alone (Full-mouth debridment)
Intervention: 45 minutes of full-mouth debridement + subgingival application of void PLGA microspheres.
Intervention Type
Drug
Intervention Name(s)
Doxicicline
Other Intervention Name(s)
PLGA microspheres
Intervention Description
Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
Intervention Type
Procedure
Intervention Name(s)
Full-mouth debridment
Intervention Description
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 Measure Information:
Title
Probing depht (PD)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical attachment level (CAL)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enilson A Sallum, PhD
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School, State University of Campinas
City
Piracicaba
State/Province
São Paulo
ZIP/Postal Code
13414-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Locally Delivered Doxycycline Adjunct to Nonsurgical Periodontal Therapy.
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