Effectiveness of Photodynamic Therapy Combined With Conventional Endodontic Treatment in the Disinfection of Root Canals in Patients With Apical Lesion: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universidad de La Frontera
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- Reduction in lesion size.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Patients requiring complex dental rehabilitation due to major coronal destruction
- •Individuals with cognitive disability making conventional treatment impossible
Arms & Interventions
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
Intervention: Group 1. Placebo (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.
Intervention: Group 2 PDT (10 s) (Other)
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.
Intervention: Group 3 PDT 20 s (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Disinfection of the root canals(before treatment (T0) and after treatment (T1))
- Success rate(From treatment at 6 months)
Investigators
Naira Figueiredo Deana
Máster
Universidad de La Frontera