Evaluation of Photodynamic Therapy in Pieces With Presence of Fistula.

Not Applicable

Recruiting

• Conditions: Fistula; Periodontitis
• Interventions: Procedure: Endodontic treatment; Device: aPDT

• Registration Number: NCT06413836
• Lead Sponsor: University of Nove de Julho

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

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-01
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-09
• Study First Posted: 2024-05-14
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-06
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment	Endodontic treatment	Endodontic treatment conventional treatment
aPDT Therapy	Endodontic treatment	antimicrobial photodynamic therapy using methylene blue in surfactant solution
aPDT Therapy	aPDT	antimicrobial photodynamic therapy using methylene blue in surfactant solution

Primary Outcome Measures

Name	Time	Method
Fistula presence	Day 15	Clinical observation to check presence or absence of fistula

Secondary Outcome Measures

Name	Time	Method
Radiographic register	Day 0 and Day 30	Radiolucent radiograph analysis defining improvement or absence of improvement of the bone lesion.

Trial Locations

Locations (1)

UCU; 🇺🇾 Montevideo, Uruguay