Evaluation of Local Doxycycline in Smokers With Chronic Periodontitis

NCT02726646 | Completed Phase 2 DMC

• 1 other identifier: 0952015
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Local Drug Delivery; Antibiotics; Doxycycline; Smokers; Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Relative Clinical Attachment Level

  Measure of deep periodontal pocket to enamel-cementum junction

  6 months

Study Arms (2)

Debridement

PLACEBO COMPARATOR

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; Drug: Placebo

Debridement plus Doxycycline

EXPERIMENTAL

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; Procedure: Mechanical debridement

Interventions

Doxycycline DRUG

Application of 1 mg of doxyxycline microspheres at 4 sites (two means and two deep periodontal pockets) after mechanical debridement.

Also known as: PLGA microspheres

Debridement plus Doxycycline

Mechanical debridement PROCEDURE

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

Also known as: Full mouth debridement

Debridement; Debridement plus Doxycycline

Placebo DRUG

The application of 1 mg of microspheres placebo

Also known as: Full mouth debridement

Debridement

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Pontificia Universidade Catolica de Sao Paulo: collaborator

Study Sites (1)

Piracicaba Dental School, State University of Campinas

Piracicaba, São Paulo, 13414-903, Brazil

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Rafaela V Clima da Silva, MD

  School of Odontology of Piracicaba - Unicamp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: April 4, 2016
• Study Start: June 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: October 11, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)