Evaluation of Photodynamic Therapy in Pieces With Presence of Fistula.

NCT06413836 | Recruiting

• 1 other identifier: UCUUNINOVE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Periodontitis; Fistula

Keywords

Periodontitis; Fistula aPDT; Methylene Blue

Outcome Measures

Primary Outcomes (1)

• Fistula presence

  Clinical observation to check presence or absence of fistula

  Day 15

Secondary Outcomes (1)

• Radiographic register

  Day 0 and Day 30

Study Arms (2)

aPDT Therapy

EXPERIMENTAL

antimicrobial photodynamic therapy using methylene blue in surfactant solution

Device: aPDT; Procedure: Endodontic treatment

conventional treatment

SHAM COMPARATOR

Endodontic treatment conventional treatment

Procedure: Endodontic treatment

Interventions

aPDT DEVICE

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..

aPDT Therapy

Endodontic treatment PROCEDURE

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.

aPDT Therapy; conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a single-rooted tooth with apical periodontitis and the presence of fistula.
• Patients must be over 18 years of age.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

UCU

Montevideo, 11200, Uruguay

RECRUITING

MeSH Terms

Conditions

Periodontitis; Fistula

Interventions

Endodontics

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Renato Prates

  University of Nove de Julho

  STUDY DIRECTOR

Central Study Contacts

Carolina Wince

CONTACT

099637248; caritowince@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resercher

Model Details: 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.

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 14, 2024
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

UR (1)