Clinical trial NCT06413836: Evaluation of Photodynamic Therapy in Pieces With Presence of Fistula.
Official title: Effect of the Photodynamic Therapy Mediated by Methylene Blue in Surfactant Medium as an Adjuvant in the Treatment of Parts With Apical Periodontitis and the Presence of Fistula: A Randomized, Controlled Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Fistula
Keywords: Periodontitis
Fistula aPDT
Methylene Blue
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Fistula presence
timeFrame: Day 15
Secondary outcomes:
measure: Radiographic register
timeFrame: Day 0 and Day 30
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: UCU
Study officials:
affiliation: University of Nove de Julho
name: Renato Prates
role: STUDY_DIRECTOR
References: