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NCT Number: NCT02824601

Photodynamic Therapy in Endodontic Treatment

This randomized clinical trial evaluated the effectiveness of supplemental photodynamic therapy (PDT) in optimizing the removal of bacteria and endotoxins from primarily infected root canals after one-visit and two-visit treatments.Twenty-four primarily infected root canals with apical periodontitis were selected and randomly divided into one-visit (n=12) and two-visit treatments (n=12). Chemo-mechanical preparation (CMP) was performed by using the single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17% Ethylenediamine tetraacetic acid (EDTA). The photosensitizer agent (methylene blue 10 mg/mL) was applied to root canals for 60 seconds and submitted to laser with a potency of 60 milliwatts (mW) and energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit treatment and after 14-day inter-appointment medication with Ca(OH)2 + saline solution (SSL) in the two-visit treatment. Samples were collected before and after root canal procedures. Endotoxins were quantified by chromogenic limulus amebocyte lysate assay. Culture techniques were used to determine bacterial colony-forming unit counts.

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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universidade Estadual Paulista Júlio de Mesquita Filho

São José dos Campos, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • single-rooted maxillary ones with primary endodontic infection and showing presence of one root canal and absence of periodontal pockets deeper than 4 mm.

Exclusion criteria

  • Those who had received antibiotic treatment during the past three months were excluded.
  • The teeth that could not be isolated with rubber dam were also excluded.
  • Presence of root canal calcification.

Treatment and study plan

laser

Device

1-visit-treatment (n=12): Chemomechanical preparation (CMP) - CMP was performed by using the single-file reciprocating technique + 2.5% NaOCL and 17% EDTA. Methylene blue was applied to root canals for 60 seconds and submitted to laser with a potency of 60 mW and energy density of 129 J/cm2 for 120 seconds after CMP

Other names: PDT

Calcium hydroxide

Drug

2-visit-treatment (n=12): Chemomechanical preparation (CMP) + Ca(OH)2 + SSL medication for 14-days + PDT. CMP was performed by using the single-file reciprocating technique + 2.5% NaOCL and 17% EDTA. Methylene blue was applied to root canals for 60 seconds and submitted to laser with a potency of 60 mW and energy density of 129 J/cm2 for 120 seconds after 14-days of intracanal medication

Primary outcomes

  1. Change in the Determination of Total Cultivable Bacterial Count

    Time frame: At Baseline and after 14-day intracanal medication

    Briefly, the transport media containing the root canal samples were thoroughly shaken for 60 seconds. Serial 10-fold dilutions were made up to 10-4 in tubes containing fastidious anaerobe broth (FAB; Lab M, Bury, UK). Fifty microliters of the serial dilutions was plated onto 5% defibrinated sheep blood fastidious anaerobe agar (FAA; LabM) by using sterile plastic spreaders to culture non-selectively obligate anaerobes and facultative anaerobes. The plates were incubated at 37°C in anaerobic atmosphere for up to 14 days. After this period, colony-forming units (CFUs) were visually quantified for each plate.

Secondary outcomes

  1. Change in the Quantification of Endotoxin Concentration

    Time frame: At Baseline and after 14-day intracanal medication

    The kinetic chromogenic limulus amebocyte lysate (LAL) assay was used for quantification of endotoxins, with Escherichia coli endotoxin being used as standard. For the test, 100 mL of apyrogenic water (reaction blank), five standard endotoxin solutions [0.005-50 endotoxin units (EU/mL)], root canal samples, and positive controls (root canal samples contaminated with a known concentration of endotoxin, i.e. 10 EU/mL) were added to a 96-well apyrogenic plate. The tests were carried out in quadruplicate. The plate was incubated at 37°C±1°C for 10 minutes in a Kinetic reader, which was coupled to a microcomputer by means of a software. Next, 100 mL of chromogenic reagent was added to each well. The software continuously monitored absorbance at 405 nm in each microplate well and automatically calculated the log/log linear correlation.

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

Does Supplemental Photodynamic Therapy Optimize the Disinfection of Bacteria and Endotoxins in One-visit and Two-visit Root Canal Therapy? A Randomized Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 6, 2016
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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