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Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers

NCT03039244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-10-26

No results posted yet for this study

Summary

The study proposes to assess the effect of multiple applications of antimicrobial Photodynamic Therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in smokers without use of antibiotics. Twenty smokers with a clinical diagnosis of chronic periodontitis will be treated in a split-mouth design study to either aPDT associated with scaling and root planing (SRP) or SRP 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 four episodes (at days 0, 2, 7 and 14). All patients will be monitored for 90 days. 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 (nsPT). Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Gingival crevicular fluid samples will be collected (at Day 0, 14, 30 and 90 after the nsPT) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex) will be evaluated. Salivary cotinine levels will also be evaluated at baseline. Data obtained will be statistically analyzed.

Conditions

  • Chronic Periodontitis

Interventions

OTHER

Photodynamic therapy

After Scaling and root planing, periodontal pockets will receive the antimicrobial (aPDT) photodynamic therapy. Shortly phenothiazine hydrochloride photosensitizing is applied at a concentration of 10mg/mL from the pocket bottom to the gingival margin. After 1 minute, irrigation is performed from periodontal pockets with distilled water to remove excess dye. The stained area is then irradiated with a diode laser with 660 nm of wavelength and maximum power of 60 mW/cm², through a fiber-optic probe of 0.6 mm diameter. Exposure to radiation will occur at six sites per tooth under treatment, making the total time of 1 minute per element, or the equivalent of 10 seconds per site. The aPDT applications will be repeated in the same way until the second week in the days 2, 7 and 14.

OTHER

Control Group

A sham procedure will be held simultaneously in pairs of contralateral teeth selected that will not receive the aPDT (control group).

DEVICE

Diode Laser

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-01
Primary Completion
2016-12-01
Completion
2017-09-01

Countries

  • Brazil

Study Locations

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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 NCT03039244 on ClinicalTrials.gov