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Photodynamic Therapy in Endodontic Treatment

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ClinicalTrials.gov Identifier: NCT02824601
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Frederico Canato Martinho, Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endodontic Disease Device: Laser Drug: Calcium hydroxide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: One-visit treatment PDT
Intervention: Chemo-mechanical preparation (CMP) was performed by using the single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17% EDTA. Next, the root canals were irrigated with 10 mL of saline solution, with calcium hydroxide medication being neutralized with 0.5% citric acid. Afterwards, 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 mW and energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit treatment
Device: Laser
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 Name: PDT

Experimental: Two-visit treatment PDT
Intervention: Chemo-mechanical preparation (CMP) was performed by using the single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17% EDTA. In the following, 14-day inter-appointment medication with Ca(OH)2 + SSL was placed in the root canal. After 14 days with intracanal medication, the tooth was isolated for surgery and disinfection, including removal of provisional restoration. Next, the root canals were irrigated with 10 mL of saline solution, with calcium hydroxide medication being neutralized with 0.5% citric acid. Afterwards, 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 mW and energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit treatment
Device: Laser
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 Name: PDT

Drug: Calcium hydroxide
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824601


Locations
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Brazil
Universidade Estadual Paulista Júlio de Mesquita Filho
São José dos Campos, São Paulo, Brazil
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Principal Investigator: Frederico C Martinho, PhD Universidade Estadual Paulista Júlio de Mesquita Filho
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Responsible Party: Frederico Canato Martinho, DDS, Ms, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02824601    
Other Study ID Numbers: 43555515.9.0000.0077
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs