Clinical trial NCT05916859: Effectiveness of Photodynamic Therapy in the Disinfection of Root Canals in Patients With Apical Lesion
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endodontic Treatment
Periapical Diseases
Keywords: Photodynamic Therapy
apical lesion
endodontic treatment
infra-red laser
Lead sponsor: Universidad de La Frontera
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in lesion size.
timeFrame: From treatment at 6 months
Secondary outcomes:
measure: Disinfection of the root canals
timeFrame: before treatment (T0) and after treatment (T1)
measure: Success rate
timeFrame: From treatment at 6 months
Other outcomes:
measure: adverse events
timeFrame: From treatment at 6 months
Locations:
city: Santiago
country: Chile
facility: Universidad San Sebastián
Study officials:
affiliation: Universidad de La Frontera
name: Nilton Alves, PhD
role: PRINCIPAL_INVESTIGATOR
References: