Endodontic TreatmentPDTNCT05916859
Effectiveness of Photodynamic Therapy in the Disinfection of Root Canals in Patients With Apical Lesion
A study testing Group 2 PDT (10 s) and Group 3 PDT 20 s in people with Endodontic Treatment and Periapical Diseases, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
The object of the present study is to compare the effectiveness of conventional endodontic treatment with that of endodontic treatment combined with Photodynamic Therapy (PDT) in patients with apical lesion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endodontic Treatment, Periapical Diseases
- What is being tested?
- Group 2 PDT (10 s) and Group 3 PDT 20 s
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteChile
- Study dates
- 1 Apr 2023to 1 Apr 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for this study must comply with the following for randomization:
- Adult patients of either sex
- No general biological risk
- At least 1 molar with pulp necrosis and apical lesion
Who cannot join
- Pregnancy
- Patients requiring complex dental rehabilitation due to major coronal destruction
- Individuals with cognitive disability making conventional treatment impossible
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Universidad San Sebastián
Santiago
Hector Monardes
About this study
Official title: Effectiveness of Photodynamic Therapy Combined With Conventional Endodontic Treatment in the Disinfection of Root Canals in Patients With Apical Lesion: a Randomized Clinical Trial
The object of the present study is to compare the effectiveness of conventional endodontic treatment with that of endodontic treatment combined with Photodynamic Therapy (PDT) in patients with apical lesion. Clinical and radiographic examination of the patients will be used to evaluate the presence of apical lesion, size of the lesion, and PAI index. Microbiological examination (evaluation of UFC/ml) will be carried out to assess the disinfection of the root canals. The success rate of the treatment will also be assessed. Endodontic treatment will be carried out in accordance with habitual standards and practices. PDT will be applied with diode laser (660 nm, 100 mW) and methylene blue will be used as photosensitizer (PS). Patients of the Endodontics Service of Universidad San Sebastián (Santiago campus) will be recruited for the study.
Read the detailed description
The object of the present study is to compare the effectiveness of conventional endodontic treatment with that of endodontic treatment combined with PDT in patients with apical lesion. A randomized, clinical, superiority trial will be carried out, controlled, blinded and masked, with 3 parallel arms.
The patient sample will be randomized in 3 treatment groups: the first is the placebo group which will receive conventional endodontic treatment (ET) and a simulated treatment with the equipment in which no radiation will be emitted; the second group will receive conventional ET associated with PDT with diode laser at 660 nm, fluence 10 s/canal; and the third group will receive conventional ET associated with PDAT with laser at 660 nm, 20 s/canal. The photosensitizer used in the PDT will be methylene blue.
Clinical and radiographic examination of all the patients will be used to obtain baseline values (T0) and values 6 months post-treatment (T1). The presence and size of apical lesion will be assessed at T0 and T1, the percentage reduction of the lesion will be calculated and the PAI index will be used as a scoring system to assess the lesion. The success rate will be assessed for each group 6 months after completion of the treatment. Disinfection of the root canals will be assessed by analysis of colony formation (ufc/ml); biological samples will be taken with paper cones inserted into the root canals to the apical region at two moments: Baseline (before treatment, T0); after instrumentation with PDT (experimental groups) and without PDT (placebo group). Adverse events will be analysed; a serious adverse event for this study is any unfavourable odontological event that the investigators believe to bear a causal relation with the experimental intervention.
- Conditions
- Endodontic Treatment, Periapical Diseases
- Being tested
- Group 2 PDT (10 s), Group 3 PDT 20 s, Group 1. Placebo
- Keywords
- Photodynamic Therapy, apical lesion, endodontic treatment, infra-red laser
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 2 PDT (10 s)Other
- Conventional endodontic treatment associated with PDT (10 s)
Group 3 PDT 20 sOther
Conventional endodontic treatment associated with PDAT (20 s)
Group 1. PlaceboOther
Conventional endodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Placebo | Placebo comparator | routine endodontic treatment will be applied and the application of laser will be simulated with the equipment, but no radiation will be emitted Receives: Other: Group 1. Placebo |
| Group 2. PDT 10 s | Experimental | Conventional ET + PDT. PDT will be carried out with diode laser with optical fibre coupled to the equipment (660 nm, 100 mW, 10 s). The photosensitizer used will be methylene blue. Receives: Other: Group 2 PDT (10 s) |
| Group 3: PDT 20 s | Experimental | Conventional ET + PDAT. PDAT will be carried out with diode laser with optical fibre coupled to the equipment (660 nm, 100 mW, 20 s). The photosensitizer used will be methylene blue. Receives: Other: Group 3 PDT 20 s |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in lesion size.
The lesion will be measured vertically and horizontally, and the size difference between the start of treatment and 6 months after treatment will be evaluated. The lesion will also be evaluated by the PAI index score. Interpretation of radiographs and PAI scores will be carried out by experienced endodontists.
Measured: From treatment at 6 months
Secondary outcomes (2)
Disinfection of the root canals
Disinfection of the root canals will be evaluated by analysis of colony formation (ufc/ml). To assess colony formation (ufc/ml) in the root canal, biological samples will be taken with paper cones inserted into the root canals to the apical region at two moments: Baseline (before treatment, T0); after instrumentation with PDT (experimental groups) and without PDT (placebo group). Three paper cones will be inserted into the root canals for 30 s. Routine microbiological analysis will be performed. Disinfection of the canal will be evaluated by comparing colony formation in each group at T0 and T1. Which treatment promotes the greatest disinfection will also be determined.
Measured: before treatment (T0) and after treatment (T1)
Success rate
Success rate of the treatment, measured after 6 months, based on the clinical results (absence of clinical signs and symptoms) and on the radiographic results (diminution of the lesion and absence of root resorption, PAI index score). The analyses will be carried out by two calibrated researchers, who will be blinded to the patient's assignment to a treatment group. The success rate will be assessed for each group 6 months after completion of ET.
Measured: From treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
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 Endodontic TreatmentStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naira Figueiredo Deana, Universidad de La Frontera
- Investigators
- Nilton Alves, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916859
- Sponsor's protocol ID
- Folio N°062/21
- Other IDs
- DI21-0033
- Acronym
- PDT
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alves N, Deana NF, Abarca J, Monardes H, Betancourt P, Zaror C. Root Canal Disinfection in Permanent Molars with Apical Lesion by Antimicrobial Photodynamic Therapy: Protocol for a Blind Randomized Clinical Trial. Photobiomodul Photomed Laser Surg. 2024 May;42(5):366-374. doi: 10.1089/photob.2023.0186.
PubMed 38776543
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Photodynamic Therapy Combined With Conventional Endodontic Treatment in the Disinfection of Root Canals in Patients With Apical Lesion: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05916859
- Acronym / sponsor ID
- PDT / Folio N°062/21
- Conditions
- Endodontic Treatment, Periapical Diseases
- Keywords
- Photodynamic Therapy, apical lesion, endodontic treatment, infra-red laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 23 Jun 2023 (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.
The object of the present study is to compare the effectiveness of conventional endodontic treatment with that of endodontic treatment combined with Photodynamic Therapy (PDT) in patients with apical lesion. Clinical and radiographic examination of the patients will be used to evaluate the presence of apical lesion, size of the lesion, and PAI index. Microbiological examination (evaluation of UFC/ml) will be carried out to assess the disinfection of the root canals. The success rate of the treatment will also be assessed. Endodontic treatment will be carried out in accordance with habitual standards and practices. PDT will be applied with diode laser (660 nm, 100 mW) and methylene blue will be used as photosensitizer (PS). Patients of the Endodontics Service of Universidad San Sebastián (Santiago campus) will be recruited for the study.
Detailed description
The object of the present study is to compare the effectiveness of conventional endodontic treatment with that of endodontic treatment combined with PDT in patients with apical lesion. A randomized, clinical, superiority trial will be carried out, controlled, blinded and masked, with 3 parallel arms.
The patient sample will be randomized in 3 treatment groups: the first is the placebo group which will receive conventional endodontic treatment (ET) and a simulated treatment with the equipment in which no radiation will be emitted; the second group will receive conventional ET associated with PDT with diode laser at 660 nm, fluence 10 s/canal; and the third group will receive conventional ET associated with PDAT with laser at 660 nm, 20 s/canal. The photosensitizer used in the PDT will be methylene blue.
Clinical and radiographic examination of all the patients will be used to obtain baseline values (T0) and values 6 months post-treatment (T1). The presence and size of apical lesion will be assessed at T0 and T1, the percentage reduction of the lesion will be calculated and the PAI index will be used as a scoring system to assess the lesion. The success rate will be assessed for each group 6 months after completion of the treatment. Disinfection of the root canals will be assessed by analysis of colony formation (ufc/ml); biological samples will be taken with paper cones inserted into the root canals to the apical region at two moments: Baseline (before treatment, T0); after instrumentation with PDT (experimental groups) and without PDT (placebo group). Adverse events will be analysed; a serious adverse event for this study is any unfavourable odontological event that the investigators believe to bear a causal relation with the experimental intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1. Placebo | Placebo comparator | Other: Group 1. Placeboroutine endodontic treatment will be applied and the application of laser will be simulated with the equipment, but no radiation will be emitted |
| Group 2. PDT 10 s | Experimental | Other: Group 2 PDT (10 s)Conventional ET + PDT. PDT will be carried out with diode laser with optical fibre coupled to the equipment (660 nm, 100 mW, 10 s). The photosensitizer used will be methylene blue. |
| Group 3: PDT 20 s | Experimental | Other: Group 3 PDT 20 sConventional ET + PDAT. PDAT will be carried out with diode laser with optical fibre coupled to the equipment (660 nm, 100 mW, 20 s). The photosensitizer used will be methylene blue. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients of either sex
- No general biological risk
- At least 1 molar with pulp necrosis and apical lesion
Key exclusion criteria (3 listed)
- Pregnancy
- Patients requiring complex dental rehabilitation due to major coronal destruction
- Individuals with cognitive disability making conventional treatment impossible
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 |
|---|---|---|
| Group 2 PDT (10 s)- Conventional endodontic treatment associated with PDT (10 s) | Other | Group 2. PDT 10 s |
| Group 3 PDT 20 sConventional endodontic treatment associated with PDAT (20 s) | Other | Group 3: PDT 20 s |
| Group 1. PlaceboConventional endodontic treatment | Other | Group 1. Placebo |
Primary outcome
Reduction in lesion size.
Time frame: From treatment at 6 months
The lesion will be measured vertically and horizontally, and the size difference between the start of treatment and 6 months after treatment will be evaluated. The lesion will also be evaluated by the PAI index score. Interpretation of radiographs and PAI scores will be carried out by experienced endodontists.
2 secondary outcomes
Disinfection of the root canals
Time frame: before treatment (T0) and after treatment (T1)
Success rate
Time frame: From treatment at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Derived from this study: PubMed 38776543Alves N, Deana NF, Abarca J, Monardes H, Betancourt P, Zaror C. Root Canal Disinfection in Permanent Molars with Apical Lesion by Antimicrobial Photodynamic Therapy: Protocol for a Blind Randomized Clinical Trial. Photobiomodul Photomed Laser Surg. 2024 May;42(5):366-374. doi: 10.1089/photob.2023.0186.
- Individual participant dataSharing planned: No
Related trials for Endodontic Treatment
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
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.
Nilton Alves, PhD principal investigator
Universidad de La Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 2 PDT (10 s) and Group 3 PDT 20 s in people with Endodontic Treatment and Periapical Diseases, run by Universidad de La Frontera at 1 site in Chile.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Jun 2023. 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 Chile. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilton Alves, PhD (993966898 ext. 56, nilton.alves@ufrontera.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in lesion size. (time frame: From treatment at 6 months). 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 NCT05916859, 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 23 Jun 2023.