- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02824601
Photodynamic Therapy in Endodontic Treatment
July 1, 2016 updated by: Frederico Canato Martinho, Universidade Estadual Paulista Júlio de Mesquita Filho
Does Supplemental Photodynamic Therapy Optimize the Disinfection of Bacteria and Endotoxins in One-visit and Two-visit Root Canal Therapy? A Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
São José dos Campos, São Paulo, Brazil
- Universidade Estadual Paulista Júlio de Mesquita Filho
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
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:
|
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
|
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:
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At Baseline and after 14-day intracanal medication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At Baseline and after 14-day intracanal medication
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frederico C Martinho, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
June 24, 2016
First Submitted That Met QC Criteria
July 1, 2016
First Posted (Estimate)
July 6, 2016
Study Record Updates
Last Update Posted (Estimate)
July 6, 2016
Last Update Submitted That Met QC Criteria
July 1, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43555515.9.0000.0077
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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