NCT05916859

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 23, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

June 14, 2023

Last Update Submit

June 22, 2023

Conditions

Endodontic TreatmentPeriapical Diseases

Keywords

Photodynamic Therapyapical lesionendodontic treatmentinfra-red laser

Outcome Measures

Primary Outcomes (1)

  • 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.

    From treatment at 6 months

Secondary Outcomes (2)

  • Disinfection of the root canals

    before treatment (T0) and after treatment (T1)

  • Success rate

    From treatment at 6 months

Other Outcomes (1)

  • adverse events

    From treatment at 6 months

Study Arms (3)

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

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.

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.

Other: Group 3 PDT 20 s

Interventions

Group 2 PDT (10 s)OTHER

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

Group 2. PDT 10 s
Group 3 PDT 20 sOTHER

Conventional endodontic treatment associated with PDAT (20 s)

Group 3: PDT 20 s
Group 1. PlaceboOTHER

Conventional endodontic treatment

Group 1. Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Patients requiring complex dental rehabilitation due to major coronal destruction
  • Individuals with cognitive disability making conventional treatment impossible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Sebastián

Santiago, Chile

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38776543DERIVED

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Study Officials

  • Nilton Alves, PhD

    Universidad de La Frontera

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilton Alves, PhD

CONTACT

993966898nilton.alves@ufrontera.cl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Máster

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 23, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

June 23, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)