Periodontitis, Fistula
Conditions
Keywords
Periodontitis, Fistula aPDT, Methylene Blue
Brief summary
The goal of this clinical trial is to learn if adjuvant antimicrobial photodynamic therapy (aPDT) can help in the treatment in patients with pieces with apical periodontitis and the presence of fistula, in terms of reducing symptoms, resolution of fistula and the clinical signs of inflammation at the oral mucose, as well as, evaluation radiographic parameters. Participants will undergo conventional endodontic treatment at Group I (n=15) and will undergo conventional endodontic treatment combined with antimicrobial photodynamic therapy at Group II(n=15).
Detailed description
The calculation of the sample size was conducted with the statistical software G-Power 3.1 applying the chi-square homogeneity test. Identical sample sizes were considered for the aPDT group and the sham group. The percentage of type error was set at 5% and the statistical power at 80%, obtaining n = 30 considering 10% losses. The distribution of data within each group and the homogeneity of the variants will be verified for the choice of an analysis of variance or not. With this information the most proper statistical test will be conducted. The sample size calculation is based on the literature and a 5% significance level will be adopted
Interventions
DEVICEaPDT
Mechanized endodontic treatment using an endodontic rotatory device (DENTSPLY) will be used to prepare the root canals. Following, it will be applied the methylene blue solution in surfactant medium and after 1 minute a diode laser equipment (DMC THERAPY/EC, Sao Carlos, Brazil) will be used to shine light at a wavelength of 660nm, 100 mW (miliWatts) and irradiation time of 3 min. CaOH (calcium hydroxide) paste will be applied at the root canals canals as a long-term dressing for endodontic treatment..
PROCEDUREEndodontic treatment
Mechanized endodontic treatment using an endodontic rotatory device (DENTSPLY) will be used to prepare the root canals. Following, it will be applied the methylene blue solution in surfactant medium and after 1 minute a diode laser equipment (DMC, THERAPY/EC, Sao Carlos, Brazil) will be used with an aluminium foil at the tip of the equipment to block light and use during 3 min as study group. CaOH (calcium hydroxide) will be applied at the root canals as a long-term dressing for endodontic treatment.
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
All participants will receive conventional endodontic treatment. The study group will receive antimicrobial photodynamic therapy with methylene blue application followed by active diode laser illumination. The control group will receive methylene blue solution and a simulation of laser application, which will be achieved by using an aluminum foil barrier placed at the tip of the equipment to block light in the control group. During this process, the participant will receive googles which aid eye protection and helps masking. The operator will wear protective glasses, which will aid in protection. Pre-irradiation and irradiation times will be the same at both groups.
Intervention model description
Control Group (1): Mechanized endodontic treatment with CaOH (calcium hydroxide) medication between sessions. This medicine is the most commonly used in all conventional endodontic treatments. Study Group (2:) Mechanized endodontic treatment with CaOH (calcium hydroxide) medication following application of photodynamic therapy with methylene blue applied in surfactant medium.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients must have a single-rooted tooth with apical periodontitis and the presence of fistula. Patients must be over 18 years of age.
Exclusion criteria
Patients with comorbidities such as cancer, diabetes, coagulation diseases, and anemia; Patients undergoing orthodontic treatment; Patients with periodontal pockets deeper than 4 mm; Patients taking antibiotics; Pregnant or lactating patients; Patients with parts that present the impossibility of performing absolute isolation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fistula presence | Day 15 | Clinical observation to check presence or absence of fistula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic register | Day 0 and Day 30 | Radiolucent radiograph analysis defining improvement or absence of improvement of the bone lesion. |
Countries
Uruguay
Contacts
Primary ContactCarolina Wince
Outcome results
None listed