Effectiveness of Photodynamic Therapy in the Disinfection of Root Canals in Patients With Apical Lesion

NCT ID: NCT05916859

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-04-01

Brief 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. 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.

Conditions

Endodontic Treatment; Periapical Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1. Placebo

routine endodontic treatment will be applied and the application of laser will be simulated with the equipment, but no radiation will be emitted

Group Type: PLACEBO_COMPARATOR

Group 1. Placebo

Intervention Type: OTHER

Conventional endodontic treatment

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 Type: EXPERIMENTAL

Group 2 PDT (10 s)

Intervention Type: OTHER

\- Conventional endodontic treatment associated with PDT (10 s)

Group 3: PDT 20 s

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.

Group Type: EXPERIMENTAL

Group 3 PDT 20 s

Intervention Type: OTHER

Conventional endodontic treatment associated with PDAT (20 s)

Interventions

Group 2 PDT (10 s)

\- Conventional endodontic treatment associated with PDT (10 s)

Intervention Type: OTHER

Group 3 PDT 20 s

Conventional endodontic treatment associated with PDAT (20 s)

Intervention Type: OTHER

Group 1. Placebo

Conventional endodontic treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients eligible for this study must comply with the following for randomization:

1. Adult patients of either sex

2. No general biological risk

3. At least 1 molar with pulp necrosis and apical lesion

Exclusion Criteria

1. Pregnancy

2. Patients requiring complex dental rehabilitation due to major coronal destruction

3. Individuals with cognitive disability making conventional treatment impossible

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de La Frontera

OTHER

Sponsor Role: lead

Responsible Party

Naira Figueiredo Deana

Máster

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilton Alves, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de La Frontera

Locations

Universidad San Sebastián

Santiago, , Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Nilton Alves, PhD

Role: CONTACT

nilton.alves@ufrontera.cl

993966898 ext. 56

Facility Contacts

Hector Monardes

Role: primary

References

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.

Reference Type: DERIVED

PMID: 38776543 (View on PubMed)

Other Identifiers

DI21-0033

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Folio N°062/21

Identifier Type: -

Identifier Source: org_study_id