Endodontic DiseasePhase 2NCT02824601
Photodynamic Therapy in Endodontic Treatment
A Phase 2 study testing Laser and Calcium hydroxide in people with Endodontic Disease, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- Laser and Calcium hydroxide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- single-rooted maxillary ones with primary endodontic infection and showing presence of one root canal and absence of periodontal pockets deeper than 4 mm.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Paulista Júlio de Mesquita Filho
São José dos Campos, São Paulo
About this study
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
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.
- Conditions
- Endodontic Disease
- Being tested
- Laser, Calcium hydroxide
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserDevice
Also called PDT
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
Calcium hydroxideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| One-visit treatment PDT | Experimental | 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 Receives: Device: Laser |
| Two-visit treatment PDT | Experimental | 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 Receives: Device: Laser; Drug: Calcium hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Determination of Total Cultivable Bacterial Count
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.
Measured: At Baseline and after 14-day intracanal medication
Secondary outcomes (1)
Change in the Quantification of Endotoxin Concentration
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.
Measured: At Baseline and after 14-day intracanal medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startFeb 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Canato Martinho, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Frederico C Martinho, PhD, Principal investigator, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824601
- Sponsor's protocol ID
- 43555515.9.0000.0077
- Status last verified
- Jul 2016
- First submitted
- 24 Jun 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02824601
- Acronym / sponsor ID
- 43555515.9.0000.0077
- Conditions
- Endodontic Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-visit treatment PDT | Experimental | Device: LaserIntervention: 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 |
| Two-visit treatment PDT | Experimental | Device: Laser, Drug: Calcium hydroxideIntervention: 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- single-rooted maxillary ones with primary endodontic infection and showing presence of one root canal and absence of periodontal pockets deeper than 4 mm.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserAlso: PDT1-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 | Device | One-visit treatment PDT, Two-visit treatment PDT |
| Calcium hydroxide2-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 | Drug | Two-visit treatment PDT |
Primary outcome
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.
1 secondary outcome
Change in the Quantification of Endotoxin Concentration
Time frame: At Baseline and after 14-day intracanal medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Individual participant dataSharing planned: Yes
Related trials for Endodontic Disease
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Active, not recruiting
THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
Retreatment, Endodontic Diseases
Active, not recruiting
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Endodontically Treated Teeth, Calcium Hydroxide
Recruiting
Effect of Menstrual Phase on the Anesthetic Efficacy
Pulpitis - Irreversible
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederico C Martinho, PhD principal investigator
Universidade Estadual Paulista Júlio de Mesquita Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laser and Calcium hydroxide in people with Endodontic Disease, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Determination of Total Cultivable Bacterial Count (time frame: At Baseline and after 14-day intracanal medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.