Dental Pulp NecrosesNCT02485210
Antimicrobial Photodynamic Therapy in the Endodontic Treatment of Anterior Primary Teeth With Pulp Necrosis
A study testing Conventional Endodontic Treatment and Antimicrobial Photodynamic Therapy in people with Dental Pulp Necroses and Tooth, Nonvital, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
This randomized controlled clinical trial evaluated the immediate reduction in intracanal microbial load and the short-term clinical and radiographic progression of anterior primary teeth with pulp necrosis after conventional endodontic treatment or antimicrobial photodynamic therapy (aPDT). Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Dental Pulp Necroses, Tooth, Nonvital
- What is being tested?
- Conventional Endodontic Treatment and Antimicrobial Photodynamic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2025to 1 May 2026
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children of either sex, aged 2 to 5 years, in the primary dentition stage.
- At least one restorable single-rooted anterior primary tooth with pulp necrosis caused by deep caries or dental trauma.
- At least two-thirds of the root remaining.
- Sufficient cooperation to allow safe clinical treatment.
- No systemic antibiotic therapy during the previous 3 months.
- Written informed consent provided by a parent or legal guardian.
Who cannot join
- Root resorption involving two-thirds or more of the root.
- Involvement of the permanent successor tooth crypt.
- Tooth requiring immediate extraction or not amenable to endodontic treatment.
- Compromised systemic health or uncontrolled chronic disease.
- Recent antibiotic use capable of affecting microbiological results.
- Noncooperative behavior that precluded safe clinical treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antimicrobial Photodynamic Therapy in the Endodontic Treatment of Anterior Primary Teeth With Pulp Necrosis: A Randomized Controlled Clinical Trial With Microbiological Analysis and Blinded Assessment of Clinical and Radiographic Outcomes
This randomized controlled clinical trial evaluated the immediate reduction in intracanal microbial load and the short-term clinical and radiographic progression of anterior primary teeth with pulp necrosis after conventional endodontic treatment or antimicrobial photodynamic therapy (aPDT). Seven children aged 2 to 5 years contributed 20 eligible single-rooted anterior primary teeth. Teeth were randomized to conventional endodontic treatment (10 teeth) or aPDT (10 teeth). The primary outcome was intracanal microbial load before and immediately after the assigned first-session intervention. Clinical outcomes were assessed at 7 days, 1 month, and 3 months, and radiographic outcomes were assessed at 1 and 3 months.
Read the detailed description
The tooth was the unit of randomization and analysis. Some participants contributed more than one eligible tooth and could have teeth allocated to both study arms. Each eligible tooth was independently randomized using opaque, sealed, sequentially numbered envelopes.
After coronal access and working-length determination, three sterile paper points were maintained in the root canal for 30 seconds to obtain the baseline microbiological sample (S1).
In the conventional-treatment arm, S1 collection was followed by chemomechanical preparation using K-files, 1% sodium hypochlorite, and Endo PTC. A second microbiological sample (S2) was then collected.
In the aPDT arm, S1 collection was followed by intracanal application of 0.005% methylene blue for 3 minutes. Irradiation was performed with a Therapy XT red laser in continuous-wave mode at 660 nm, with a mean radiant power of 100 mW, for 90 seconds, delivering a radiant energy of 9 J through an intracanal optical fiber. The canal was then irrigated with sterile saline, and S2 was collected. No chemomechanical preparation, instrumentation, or sodium hypochlorite irrigation was performed in the aPDT arm before S2 collection.
After S2 collection, teeth in both arms received UltraCal XS calcium hydroxide intracanal medication, a thin gutta-percha base, and provisional sealing with glass ionomer cement. After 7 days, the teeth were reopened, the intracanal medication was removed, the canals were irrigated with 1% sodium hypochlorite, and definitive root canal filling was performed using Guedes-Pinto iodoform paste. Restorative treatment was performed in a subsequent session.
Clinical assessments were performed at 7 days, 1 month, and 3 months. Radiographic assessments were performed at 1 and 3 months. Conventional rescue treatment was planned for teeth in the aPDT arm if pain, fistula, swelling, or other signs and symptoms persisted or worsened.
- Conditions
- Dental Pulp Necroses, Tooth, Nonvital
- Being tested
- Conventional Endodontic Treatment, Antimicrobial Photodynamic Therapy
- Keywords
- Primary teeth, Endodontic treatment, Antimicrobial photodynamic therapy, Pulp necrosis
- Medical subject headings
- Dental Pulp Necrosis, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Endodontic TreatmentProcedure or surgery
Following coronal access, an initial microbiological sample (S1) was collected. Chemomechanical preparation was performed using K-files, Endo PTC, and irrigation and aspiration with 1% sodium hypochlorite. A second microbiological sample (S2) was then collected. Calcium hydroxide intracanal medication was placed, and the tooth was temporarily sealed. After 7 days, the medication was removed, the canal was irrigated with 1% sodium hypochlorite, and definitive root canal filling was performed using Guedes-Pinto iodoform paste.
Antimicrobial Photodynamic TherapyProcedure or surgery
Also called aPDT
Following coronal access, an initial microbiological sample (S1) was collected. Methylene blue at 0.005% was placed inside the root canal for a 3-minute pre-irradiation period. Irradiation was performed using a Therapy XT red laser at 660 nm, 100 mW, for 90 seconds, delivering 9 J through an intracanal optical fiber. No chemomechanical preparation, instrumentation, or sodium hypochlorite irrigation was performed before S2. After irrigation with sterile saline, the second microbiological sample (S2) was collected. Calcium hydroxide intracanal medication was placed, and the tooth was temporarily sealed. After 7 days, the medication was removed, the canal was irrigated with 1% sodium hypochlorite, and definitive root canal filling was performed using Guedes-Pinto iodoform paste.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Endodontic Treatment | Active comparator | After baseline microbiological sampling, teeth underwent chemomechanical root canal preparation using K-files, 1% sodium hypochlorite, and Endo PTC. The immediate post-intervention microbiological sample was then collected. Calcium hydroxide medication and provisional sealing were placed, followed by definitive root canal filling after 7 days. Receives: Procedure: Conventional Endodontic Treatment |
| Antimicrobial Photodynamic Therapy | Experimental | After baseline microbiological sampling, teeth received intracanal 0.005% methylene blue for 3 minutes, followed by red-laser irradiation at 660 nm, 100 mW, for 90 seconds, delivering 9 J through an intracanal optical fiber. No chemomechanical preparation, instrumentation, or sodium hypochlorite irrigation was performed before the immediate post-intervention sample. Calcium hydroxide medication and provisional sealing were placed, followed by definitive root canal filling after 7 days. Conventional rescue treatment was planned if symptoms persisted or worsened. Receives: Procedure: Antimicrobial Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intracanal Microbial Load From Baseline to Immediately Post-intervention
Viable intracanal microorganisms were quantified as colony-forming units per milliliter and transformed to log10 CFU/mL. Samples were collected using three sterile paper points maintained in the root canal for 30 seconds. S1 was collected before the assigned intervention. S2 was collected after chemomechanical preparation in the conventional-treatment arm and immediately after aPDT in the experimental arm. Change was calculated as S2 minus S1; more negative values indicate a greater reduction in viable microbial load.
Measured: Baseline and immediately post-intervention on Day 0
Secondary outcomes (4)
Number of Treated Teeth With Clinical Signs or Symptoms
The presence or absence of pain, fistula, swelling, abscess, pathological mobility, need for systemic antibiotics, emergency dental care, or an additional intervention related to the treated tooth was recorded at each follow-up. The outcome was reported as the number of teeth with at least one clinical sign or symptom.
Measured: 7 days, 1 month, and 3 months
Number of Treated Teeth With a Periapical or Periradicular Lesion
The presence or absence of a periapical or periradicular lesion was assessed on standardized radiographs by two blinded examiners. The outcome was reported as the number of teeth with a lesion at each follow-up.
Measured: 1 month and 3 months.
Number of Treated Teeth Without Radiographic Worsening
Standardized radiographs were assessed by two blinded examiners. Absence of radiographic worsening was defined as no progression or development of adverse periapical or periradicular findings, with maintenance or improvement of the radiographic condition.
Measured: 1 month and 3 months
Number of Treated Teeth With Pathological Root Resorption
The presence or absence of pathological root resorption was assessed on standardized radiographs by two blinded examiners. The outcome was reported as the number of teeth with pathological root resorption at each follow-up.
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study start1 Nov 2025
- Primary completion1 Feb 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp NecrosesStudies 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
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
- Investigators
- Sandra Bussadori, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485210
- Sponsor's protocol ID
- aPDTEndo
- Other IDs
- 19373019.1.0000.5511
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2015
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
da Mota AC, Goncalves ML, Bortoletto C, Olivan SR, Salgueiro M, Godoy C, Altavista OM, Pinto MM, Horliana AC, Motta LJ, Bussadori SK. Evaluation of the effectiveness of photodynamic therapy for the endodontic treatment of primary teeth: study protocol for a randomized controlled clinical trial. Trials. 2015 Dec 3;16:551. doi: 10.1186/s13063-015-1086-2.
PubMed 26635011
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Photodynamic Therapy in the Endodontic Treatment of Anterior Primary Teeth With Pulp Necrosis: A Randomized Controlled Clinical Trial With Microbiological Analysis and Blinded Assessment of Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT02485210
- Acronym / sponsor ID
- aPDTEndo
- Conditions
- Dental Pulp Necroses, Tooth, Nonvital
- Keywords
- Primary teeth, Endodontic treatment, Antimicrobial photodynamic therapy, Pulp necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 30 Jun 2015 (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 controlled clinical trial evaluated the immediate reduction in intracanal microbial load and the short-term clinical and radiographic progression of anterior primary teeth with pulp necrosis after conventional endodontic treatment or antimicrobial photodynamic therapy (aPDT). Seven children aged 2 to 5 years contributed 20 eligible single-rooted anterior primary teeth. Teeth were randomized to conventional endodontic treatment (10 teeth) or aPDT (10 teeth). The primary outcome was intracanal microbial load before and immediately after the assigned first-session intervention. Clinical outcomes were assessed at 7 days, 1 month, and 3 months, and radiographic outcomes were assessed at 1 and 3 months.
Detailed description
The tooth was the unit of randomization and analysis. Some participants contributed more than one eligible tooth and could have teeth allocated to both study arms. Each eligible tooth was independently randomized using opaque, sealed, sequentially numbered envelopes.
After coronal access and working-length determination, three sterile paper points were maintained in the root canal for 30 seconds to obtain the baseline microbiological sample (S1).
In the conventional-treatment arm, S1 collection was followed by chemomechanical preparation using K-files, 1% sodium hypochlorite, and Endo PTC. A second microbiological sample (S2) was then collected.
In the aPDT arm, S1 collection was followed by intracanal application of 0.005% methylene blue for 3 minutes. Irradiation was performed with a Therapy XT red laser in continuous-wave mode at 660 nm, with a mean radiant power of 100 mW, for 90 seconds, delivering a radiant energy of 9 J through an intracanal optical fiber. The canal was then irrigated with sterile saline, and S2 was collected. No chemomechanical preparation, instrumentation, or sodium hypochlorite irrigation was performed in the aPDT arm before S2 collection.
After S2 collection, teeth in both arms received UltraCal XS calcium hydroxide intracanal medication, a thin gutta-percha base, and provisional sealing with glass ionomer cement. After 7 days, the teeth were reopened, the intracanal medication was removed, the canals were irrigated with 1% sodium hypochlorite, and definitive root canal filling was performed using Guedes-Pinto iodoform paste. Restorative treatment was performed in a subsequent session.
Clinical assessments were performed at 7 days, 1 month, and 3 months. Radiographic assessments were performed at 1 and 3 months. Conventional rescue treatment was planned for teeth in the aPDT arm if pain, fistula, swelling, or other signs and symptoms persisted or worsened.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Endodontic Treatment | Active comparator | Procedure: Conventional Endodontic TreatmentAfter baseline microbiological sampling, teeth underwent chemomechanical root canal preparation using K-files, 1% sodium hypochlorite, and Endo PTC. The immediate post-intervention microbiological sample was then collected. Calcium hydroxide medication and provisional sealing were placed, followed by definitive root canal filling after 7 days. |
| Antimicrobial Photodynamic Therapy | Experimental | Procedure: Antimicrobial Photodynamic TherapyAfter baseline microbiological sampling, teeth received intracanal 0.005% methylene blue for 3 minutes, followed by red-laser irradiation at 660 nm, 100 mW, for 90 seconds, delivering 9 J through an intracanal optical fiber. No chemomechanical preparation, instrumentation, or sodium hypochlorite irrigation was performed before the immediate post-intervention sample. Calcium hydroxide medication and provisional sealing were placed, followed by definitive root canal filling after 7 days. Conventional rescue treatment was planned if symptoms persisted or worsened. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children of either sex, aged 2 to 5 years, in the primary dentition stage.
- At least one restorable single-rooted anterior primary tooth with pulp necrosis caused by deep caries or dental trauma.
- At least two-thirds of the root remaining.
- Sufficient cooperation to allow safe clinical treatment.
- No systemic antibiotic therapy during the previous 3 months.
Key exclusion criteria (6 listed)
- Root resorption involving two-thirds or more of the root.
- Involvement of the permanent successor tooth crypt.
- Tooth requiring immediate extraction or not amenable to endodontic treatment.
- Compromised systemic health or uncontrolled chronic disease.
- Recent antibiotic use capable of affecting microbiological results.
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 |
|---|---|---|
| Conventional Endodontic TreatmentFollowing coronal access, an initial microbiological sample (S1) was collected. Chemomechanical preparation was performed using K-files, Endo PTC, and irrigation and aspiration with 1% sodium hypochlorite. A second microbiological sample (S2) was then collected. Calcium hydroxide intracanal medication was placed, and the tooth was temporarily sealed. After 7 days, the medication was removed, the canal was irrigated with 1% sodium hypochlorite, and definitive root canal filling was performed using Guedes-Pinto iodoform paste. | Procedure or surgery | Conventional Endodontic Treatment |
| Antimicrobial Photodynamic TherapyAlso: aPDTFollowing coronal access, an initial microbiological sample (S1) was collected. Methylene blue at 0.005% was placed inside the root canal for a 3-minute pre-irradiation period. Irradiation was performed using a Therapy XT red laser at 660 nm, 100 mW, for 90 seconds, delivering 9 J through an intracanal optical fiber. No chemomechanical preparation, instrumentation, or sodium hypochlorite irrigation was performed before S2. After irrigation with sterile saline, the second microbiological sample (S2) was collected. Calcium hydroxide intracanal medication was placed, and the tooth was temporarily sealed. After 7 days, the medication was removed, the canal was irrigated with 1% sodium hypochlorite, and definitive root canal filling was performed using Guedes-Pinto iodoform paste. | Procedure or surgery | Antimicrobial Photodynamic Therapy |
Primary outcome
Change in Intracanal Microbial Load From Baseline to Immediately Post-intervention
Time frame: Baseline and immediately post-intervention on Day 0
Viable intracanal microorganisms were quantified as colony-forming units per milliliter and transformed to log10 CFU/mL. Samples were collected using three sterile paper points maintained in the root canal for 30 seconds. S1 was collected before the assigned intervention. S2 was collected after chemomechanical preparation in the conventional-treatment arm and immediately after aPDT in the experimental arm. Change was calculated as S2 minus S1; more negative values indicate a greater reduction in viable microbial load.
4 secondary outcomes
Number of Treated Teeth With Clinical Signs or Symptoms
Time frame: 7 days, 1 month, and 3 months
Number of Treated Teeth With a Periapical or Periradicular Lesion
Time frame: 1 month and 3 months.
Number of Treated Teeth Without Radiographic Worsening
Time frame: 1 month and 3 months
Number of Treated Teeth With Pathological Root Resorption
Time frame: 1 month and 3 months
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 16 Sep 2026.
- Derived from this study: PubMed 26635011da Mota AC, Goncalves ML, Bortoletto C, Olivan SR, Salgueiro M, Godoy C, Altavista OM, Pinto MM, Horliana AC, Motta LJ, Bussadori SK. Evaluation of the effectiveness of photodynamic therapy for the endodontic treatment of primary teeth: study protocol for a randomized controlled clinical trial. Trials. 2015 Dec 3;16:551. doi: 10.1186/s13063-015-1086-2.
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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.
Sandra Bussadori, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Endodontic Treatment and Antimicrobial Photodynamic Therapy in people with Dental Pulp Necroses and Tooth, Nonvital, run by University of Nove de Julho 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 6 inclusion and 6 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 16 Sep 2026. 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.
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 Intracanal Microbial Load From Baseline to Immediately Post-intervention (time frame: Baseline and immediately post-intervention on Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02485210, which also lists 1 linked publication.
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 16 Sep 2026.