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Trial record 17 of 312 for:    "Periodontitis, Chronic"

Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT02726646
Recruitment Status : Completed
First Posted : April 4, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Pontificia Universidade Catolica de Sao Paulo
Information provided by (Responsible Party):
Enilson Antonio Sallum, University of Campinas, Brazil

Brief Summary:
Summary The aim of this study is to evaluate through clinical, microbiological and immunological parameters using PLGA microspheres (lactic-co-glycolic acid polyacid) containing doxycycline in periodontal therapy in smokers with chronic periodontitis. For this study, 40 patients will be selected, with an average age between 30 and 59 years old of both genders (male and female), who spontaneously seek the clinic graduate of the Piracicaba Dental School -FOP / UNICAMP, and exhibiting at least four bleeding sites, including 2 sites with a probing depth (PD) between 5 and 6 mm and two sites PS ≥7 mm in uniradiculares teeth. Patients should have a minimum of 20 teeth. Will be excluded from relevant systemic disease carriers or antibiotics used in the 6 months preceding the study. All patients will receive oral hygiene instruction and will undergo a pre-treatment, which will be held supragingival sweeps and removal of plaque retentive factors. Patients will be divided into 2 groups (DB + DOX: Debridement + Doxycycline, test group and DB: only debridement, control group) of 20 patients who will receive the following treatments: periodontal debridement ultrasound for 45 minutes associated with the local administration of 1 mg microspheres containing doxycycline, or just mechanical debridement, for each selected site. Will be assessed the following clinical parameters: gingival index (GI) Plaque Index (PI), Bleeding on Probing (BOP), Position of the gingival margin (PGM), Probing Depth (PD) and Relative Clinical Attachment Level (RCAL). The microbiological evaluation will be made by means of polymerase chain reaction - real time ( "real time" - PCR) to detect bacteria: Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Aggregatibacter actinomycetemcomitans and Prevotella intermedia. The enzyme immunoassay (LUMINEXMAGPIX) allow the detection of cytokine levels of GM-CSF, INF-γ, IL-10, IL-12, IL-13, IL-1β, IL-4, IL-6, IL-8 and TNF-α. The analysis of the proteolytic enzyme activity is accomplished by using zymography to assess MMP-8 and MMP-9. The described parameters will be evaluated at baseline, 45 and 90 days after the initial visit. The results are compared statistically by analysis of variance with repeated measures with 5% significance level.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Doxycycline Procedure: Mechanical debridement Drug: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Controlled Release System of Doxycycline in Periodontal Therapy in Smokers With Chronic Periodontitis.
Study Start Date : June 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : March 2017

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Arm Intervention/treatment
Placebo Comparator: Debridement
mechanical debridement in one session and application of 1 mg placebo microspheres in two periodontal pockts between 5 and 6 mm, and two periodontal pockts greater than or equal to 7 mm
Procedure: Mechanical debridement
Mechanical debridement (full mouth) of 45 minutes associated with the application of 1 mg of microspheres placebo in selected periodontal pockets.
Other Name: Full mouth debridement

Drug: Placebo
The application of 1 mg of microspheres placebo
Other Name: Full mouth debridement

Experimental: Debridement plus Doxycycline
mechanical debridement in one session associated with the application of 1 mg of microspheres loaded with doxycycline per periodontal pockts, two periodontal pockts between 5 and 6 mm, and two periodontal pockts greater than or equal to 7 mm
Drug: Doxycycline
Application of 1 mg of doxyxycline microspheres at 4 sites (two means and two deep periodontal pockets) after mechanical debridement.
Other Name: PLGA microspheres

Procedure: Mechanical debridement
Mechanical debridement (full mouth) of 45 minutes associated with the application of 1 mg of microspheres placebo in selected periodontal pockets.
Other Name: Full mouth debridement




Primary Outcome Measures :
  1. Relative Clinical Attachment Level [ Time Frame: 6 months ]
    Measure of deep periodontal pocket to enamel-cementum junction



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Ages Eligible for Study:   30 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients smokers but otherwise healthy
  • patients initially diagnosed with moderate or severe chronic periodontitis (according to the American Academy of Periodontology- AAP, 1999) verified the presence of radiographic periodontal pockets and bone loss;
  • Patients who have at least 4 bleeding sites with probing depth (PD)> 5 mm in uniradiculares teeth.
  • Presence of a minimum of 20 teeth;
  • formal consent to participate in research, after explaining the risks and benefits for individual not involved in it. (Resolution No. 196 of October 1996 and the Dental Code of Professional Ethics (C.F.O.) 179/93).

Exclusion Criteria:

  • periapical pulp and change Presence
  • Presence of systemic changes or use of medications (6 months prior to the study) that may influence response to periodontal treatment (eg, phenytoin, cyclosporine, calcium channel antagonists, and anti-inflammatory steroids and non-steroidal);
  • Presence hypersensitivity to tetracyclines and their derivatives;
  • Teeth with involvement fork in the case of premolars.
  • Pregnancy and lactation

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): NCT02726646


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
Pontificia Universidade Catolica de Sao Paulo
Investigators
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Principal Investigator: Rafaela V Clima da Silva, MD FOP-UNICAMP

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Responsible Party: Enilson Antonio Sallum, Doctor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02726646     History of Changes
Other Study ID Numbers: 0952015
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Enilson Antonio Sallum, University of Campinas, Brazil:
Local Drug Delivery
Antibiotics
Doxycycline
Smokers
Chronic Periodontitis

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