Photochemotherapy ReactionNCT03212729
Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Microbiological Study
A study testing ANTIMICROBIAL PHOTODYNAMIC THERAPY and Conventional endodontic treatment in people with Photochemotherapy Reaction and Dental Pulp Necrosis, run by Universidade Federal Fluminense.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Photochemotherapy Reaction, Dental Pulp Necrosis, Polymerase Chain Reaction
- What is being tested?
- ANTIMICROBIAL PHOTODYNAMIC THERAPY and Conventional endodontic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2015
- Phase
- Interventional
- 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 17 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Molecular Microbiological Study
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).
- Conditions
- Photochemotherapy Reaction, Dental Pulp Necrosis, Polymerase Chain Reaction, Infection, Enterococcal Infections, Candida
- Being tested
- ANTIMICROBIAL PHOTODYNAMIC THERAPY, Conventional endodontic treatment
- Medical subject headings
- Dental Pulp Necrosis, Infections, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANTIMICROBIAL PHOTODYNAMIC THERAPYRadiation
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.
Conventional endodontic treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | CONVENTIONAL ENDODONTIC TREATMENT Receives: Procedure: Conventional endodontic treatment |
| Test Group | Experimental | CONVENTIONAL ENDODONTIC TREATMENT ASSOCIATED WITH ANTIMICROBIAL PHOTODYNAMIC THERAPY Receives: Radiation: ANTIMICROBIAL PHOTODYNAMIC THERAPY; Procedure: Conventional endodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial photodynamic therapy (aPDT) evaluation on microorganisms erradication in canal roots after endodontic tretament and immediately use aPDT
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.
Measured: Microorganisms detection were evaluated one month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startApr 2015
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photochemotherapy ReactionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Natalia Iorio Lopes Pontes Póvoa, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212729
- Sponsor's protocol ID
- aPDT and microorganisms
- Status last verified
- Jul 2017
- First submitted
- 4 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Molecular Microbiological Study
- ClinicalTrials.gov ID
- NCT03212729
- Acronym / sponsor ID
- aPDT and microorganisms
- Conditions
- Photochemotherapy Reaction, Dental Pulp Necrosis, Polymerase Chain Reaction, Infection, Enterococcal Infections, Candida
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Conventional endodontic treatmentCONVENTIONAL ENDODONTIC TREATMENT |
| Test Group | Experimental | Radiation: ANTIMICROBIAL PHOTODYNAMIC THERAPY, Procedure: Conventional endodontic treatmentCONVENTIONAL ENDODONTIC TREATMENT ASSOCIATED WITH ANTIMICROBIAL PHOTODYNAMIC THERAPY |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| ANTIMICROBIAL PHOTODYNAMIC THERAPYThe 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. | Radiation | Test Group |
| Conventional endodontic treatmentAfter 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. | Procedure or surgery | Control Group, Test Group |
Primary outcome
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.
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 11 Jul 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ANTIMICROBIAL PHOTODYNAMIC THERAPY and Conventional endodontic treatment in people with Photochemotherapy Reaction and Dental Pulp Necrosis, run by Universidade Federal Fluminense.
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 2 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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). 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 11 Jul 2017.