Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 48 of 26556 for:    Anti-Infective Agents

Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Microbiological Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03212729
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Natalia Iorio Lopes Pontes Póvoa, Universidade Federal Fluminense

Brief Summary:
Microorganisms play a critical role in the etiology and pathogenesis of apical periodontitis. Enterococcus faecalis and Candida sp. are frequently associated with persistent infections. The aim of this study was evaluated the antimicrobial photodynamic therapy (aPDT) as an adjunct of the endodontic treatment. Ten uniradicular teeth [control group (CG)=4 and test group (TG)=6] with primary endodontic infections were analyzed. Microbiological samples were collected before and after the chemical-mechanical instrumentation (CMI), after the aPDT (for the TG) and after the temporary restorations removal (second session).

Condition or disease Intervention/treatment Phase
Photochemotherapy Reaction Dental Pulp Necrosis Polymerase Chain Reaction Infection Enterococcal Infections Candida Radiation: ANTIMICROBIAL PHOTODYNAMIC THERAPY Procedure: Conventional endodontic treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Molecular Microbiological Study
Actual Study Start Date : April 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Control Group
CONVENTIONAL ENDODONTIC TREATMENT
Procedure: Conventional endodontic treatment
After local anesthesia the supragingival calculus, biofilm and the carious tissues were removed. The access cavity preparation was completed. The crown-down technique was performed using Gates Glidden and Kerr files with an anatomic diameter compatible to the radicular canal, and the irrigation was performed with 5 mL of 2.5% NaOCl solution between each endodontic file. The working length was established 1 mm short of the radiographic apex. Smear layer was removed by rinsing the canal with 17% ethylene diamine tetra-acetic acid solution, which was left in the canal for 5 min, followed by a final irrigation with 15 mL of 2.5% NaOCl solution. Calcium hydroxide paste with paramonoclorophenol, was inserted into the canal, filling the root canal as temporary medication between the sessions. The coronal sealing was performed using Coltosol, followed by glass ionomer Maxxion R. Seven days later the root canal was filled by the hybrid Tagger technique, with a Mc Spadden condenser.

Experimental: Test Group
CONVENTIONAL ENDODONTIC TREATMENT ASSOCIATED WITH ANTIMICROBIAL PHOTODYNAMIC THERAPY
Radiation: ANTIMICROBIAL PHOTODYNAMIC THERAPY
The aPDT was performed with 0.01% methylene blue and irradiated with low-level laser therapy (InGaAIP, 660 nm; 100 mW; 40 sec) with an optical fiber-coupled. Another irradiation (3 J; 30 sec; spot size of 3 mm2) was performed in the gingiva close to the apical foramen.

Procedure: Conventional endodontic treatment
After local anesthesia the supragingival calculus, biofilm and the carious tissues were removed. The access cavity preparation was completed. The crown-down technique was performed using Gates Glidden and Kerr files with an anatomic diameter compatible to the radicular canal, and the irrigation was performed with 5 mL of 2.5% NaOCl solution between each endodontic file. The working length was established 1 mm short of the radiographic apex. Smear layer was removed by rinsing the canal with 17% ethylene diamine tetra-acetic acid solution, which was left in the canal for 5 min, followed by a final irrigation with 15 mL of 2.5% NaOCl solution. Calcium hydroxide paste with paramonoclorophenol, was inserted into the canal, filling the root canal as temporary medication between the sessions. The coronal sealing was performed using Coltosol, followed by glass ionomer Maxxion R. Seven days later the root canal was filled by the hybrid Tagger technique, with a Mc Spadden condenser.




Primary Outcome Measures :
  1. Antimicrobial photodynamic therapy (aPDT) evaluation on microorganisms erradication in canal roots after endodontic tretament and immediately use aPDT [ Time Frame: Microorganisms detection were evaluated one month later ]
    The presence or absence of E. faecalis, Candida spp. and bacteria domains in the microbiological samples was determined by using end-point PCR. Aliquots of 10 ng of the extracted DNA were used in PCR protocols for E. faecalis, Candida genus and microorganisms from bacterial domains. Positive controls consisted of DNA extracted from E. faecalis (ATCC 29212) for detection of E. faecalis species and domain bacteria and C. albicans (ATCC 10321) for Candida genus. PCR amplifications were performed in a DNA thermocycler. Amplified products were analyzed by 1% of agarose gel electrophoresis with GelRed 1X and visualized on a UV transilluminator.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with teeth with: single canal with endodontic infection, intact pulp chamber walls, necrotic pulp confirmed by sensitivity pulp tests, and clinical and radiographic evidence of asymptomatic apical periodontitis

Exclusion Criteria:

  • Patients with teeth with: gross carious lesions, root or crown fracture, previous endodontic treatment, gingival recession and periodontal pockets deeper than 4 mm.
  • Patients pregnant, lactating, with systemic diseases that could compromise the immune system, individuals who received antibiotic therapy within the previous 3 months or in immunosuppressive treatment.

Layout table for additonal information
Responsible Party: Natalia Iorio Lopes Pontes Póvoa, Professor, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT03212729     History of Changes
Other Study ID Numbers: aPDT and microorganisms
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Necrosis
Dental Pulp Necrosis
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Anti-Bacterial Agents