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Treatment of Chronic Periodontitis With Repeated Adjunctive Antimicrobial Photodynamic Therapy

NCT02734784 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-04-12

No results posted yet for this study

Summary

Chronic periodontitis (CP) is an infectious disease resulting in inflammation of the supporting structures of the teeth, progressive loss of bone loss and insertion. The aim of this study is to evaluate the effects of antimicrobial Photodynamic Therapy (aPDT) as adjuvant to periodontal surgery treatment (PST) in patients diagnosed with generalized severe chronic periodontitis (GSCP). Twenty patients with a clinical diagnosis of CP will be treated in a split-mouth design study to either aPDT associated with surgical access for scaling and root planning (SASRP) or SASRP only. aPDT will be performed by using a laser light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will occur in only one episodes. All patients will be monitored for 30 and 90 days after PST. Clinical assessment of plaque index, probing depth, clinical attachment level and bleeding on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the PST. Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the PST) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Data obtained will be statistically analyzed.

Conditions

  • Chronic Periodontitis

Interventions

PROCEDURE

Photodynamic Therapy

After a surgical access, the periodontal pockets of teeth selected to receive antimicrobial photodynamic therapy (aPDT) will be irrigated with distilled water. Shortly thereafter, the dye will be applied (phenothiazine hydrochloride- 10mg/mL) from the bottom of the pocket. After 1 minute, irrigation will be performed with distilled water to remove the excess of dye. The stained area will be irradiated with a diode laser (660 nm and a 60 mW/cm²). Six sites per tooth under treatment will be irradiated (10 seconds/ site). Teeth with furcation lesion will increase over 60 seconds into the lesion. Before the application, the supragingival plaque will be removed.

PROCEDURE

Sham Photodynamic Therapy

After a surgical access, the periodontal pockets of teeth selected will receive a simulation of antimicrobial photodynamic therapy (aPDT): irrigation with distilled water and simulated laser application. Before the application, the supragingival plaque will be removed.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Sérgio S. de Souza, Dr. · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-11-30
Completion
2016-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02734784 on ClinicalTrials.gov