## Protocol Section
### Identification Module
**NCT ID:** NCT06413836

**Acronym:** aPDT

**Brief Title:** 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

#### Organization Study ID Info
**ID:** UCUUNINOVE
#### Organization
**Class:** OTHER
**Full Name:** University of Nove de Julho
### Status Module
#### Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Nove de Julho

#### Responsible Party

**Investigator Affiliation:** University of Nove de Julho

**Investigator Full Name:** Renato Araujo Prates

**Investigator Title:** Resercher

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Periodontitis

- Fistula

**Keywords:**

- Periodontitis

- Fistula aPDT

- Methylene Blue

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** DOUBLE

**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.

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** antimicrobial photodynamic therapy using methylene blue in surfactant solution

**Intervention Names:**

- Device: aPDT

- Procedure: Endodontic treatment

**Label:** aPDT Therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Endodontic treatment conventional treatment

**Intervention Names:**

- Procedure: Endodontic treatment

**Label:** conventional treatment

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- aPDT Therapy

**Description:** 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..

**Name:** aPDT

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- aPDT Therapy

- conventional treatment

**Description:** 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.

**Name:** Endodontic treatment

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Clinical observation to check presence or absence of fistula

**Measure:** Fistula presence

**Time Frame:** Day 15

#### Secondary Outcomes

**Description:** Radiolucent radiograph analysis defining improvement or absence of improvement of the bone lesion.

**Measure:** Radiographic register

**Time Frame:** Day 0 and Day 30

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** caritowince@gmail.com

**Name:** Carolina Wince

**Phone:** 099637248

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Montevideo

**Contacts:**

***Contact 1:***

- **Email:** caritowince@gmail.com

- **Name:** Carolina Wince

- **Phone:** 099637248

- **Role:** CONTACT

**Country:** Uruguay

**Facility:** UCU

**Status:** RECRUITING

**Zip:** 11200

#### Overall Officials

**Official 1:**

**Affiliation:** University of Nove de Julho

**Name:** Renato Prates

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13395

- Name: Periapical Periodontitis

- Relevance: LOW

- As Found: Unknown

- ID: M8532

- Name: Fistula

- Relevance: HIGH

- As Found: Fistula

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000005402

- Term: Fistula

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M14517

- Name: Pulmonary Surfactants

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M11726

- Name: Methylene Blue

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
