- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06413836
Evaluation of Photodynamic Therapy in Pieces With Presence of Fistula. (aPDT)
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
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Carolina Wince
- Phone Number: 099637248
- Email: caritowince@gmail.com
Study Locations
-
-
-
Montevideo, Uruguay, 11200
- Recruiting
- UCU
-
Contact:
- Carolina Wince
- Phone Number: 099637248
- Email: caritowince@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aPDT Therapy
antimicrobial photodynamic therapy using methylene blue in surfactant solution
|
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..
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.
|
Sham Comparator: conventional treatment
Endodontic treatment conventional 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fistula presence
Time Frame: Day 15
|
Clinical observation to check presence or absence of fistula
|
Day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic register
Time Frame: Day 0 and Day 30
|
Radiolucent radiograph analysis defining improvement or absence of improvement of the bone lesion.
|
Day 0 and Day 30
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Renato Prates, University of Nove de Julho
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCUUNINOVE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontitis
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
-
Columbia UniversityCompletedPeriodontal Diseases | Generalized Moderate Chronic Periodontitis | Generalized Severe Chronic PeriodontitisUnited States
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
University of SienaNot yet recruitingPeriodontitis, AdultItaly
-
Lithuanian University of Health SciencesCompleted
-
Louisiana State University Health Sciences Center...CompletedPeriodontitis, AdultUnited States
-
University of BergenCompletedPeriodontitis | Adult Periodontitis
-
Cairo UniversityUnknownPeriodontitis, AdultEgypt
Clinical Trials on aPDT
-
University of Nove de JulhoCompletedMolar Incisor HypomineralizationBrazil
-
University of Nove de JulhoUnknown
-
The University of Texas Health Science Center,...Recruiting
-
Universidade Federal FluminenseCompletedTooth Extraction Status NosBrazil
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedType 2 Diabetes | Periodontal DiseaseBrazil
-
University of Nove de JulhoUnknownMolar Incisor Hypomineralization
-
Ondine Biomedical Inc.Unknown
-
Cardenal Herrera UniversityCompleted
-
Universidade Estadual Paulista Júlio de Mesquita...UnknownAggressive Periodontitis, Generalized