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Completed
NCT02485210
Antimicrobial Photodynamic Therapy in the Endodontic Treatment of Anterior Primary Teeth With Pulp Necrosis
Conditions: Dental Pulp Necroses, Tooth, Nonvital
Sex: All
Ages: 2 Years – 5 Years
Healthy volunteers: No
Phase: NA
Enrollment: 7
Sponsor: University of Nove de Julho
Location: University of Nove de Julho São Paulo
Summary
This randomized controlled clinical trial evaluated the immediate reduction in intracanal microbial load and the short-term clinical and radiographic progression of anterior primary teeth with pulp necrosis after conventional endodontic treatment or antimicrobial photodynamic therapy (aPDT). Seven children aged 2 to 5 years contributed 20 eligible single-rooted anterior primary teeth. Teeth were randomized to conventional endodontic treatment (10 teeth) or aPDT (10 teeth). The primary outcome was intracanal microbial load before and immediately after the assigned first-session intervention. Clinical outcomes were assessed at 7 days, 1 month, and 3 months, and radiographic outcomes were assessed at 1 and 3 months.
Eligibility Criteria
Inclusion Criteria:
* Children of either sex, aged 2 to 5 years, in the primary dentition stage.
* At least one restorable single-rooted anterior primary tooth with pulp necrosis caused by deep caries or dental trauma.
* At least two-thirds of the root remaining.
* Sufficient cooperation to allow safe clinical treatment.
* No systemic antibiotic therapy during the previous 3 months.
* Written informed consent provided by a parent or legal guardian.
Exclusion Criteria:
* Root resorption involving two-thirds or more of the root.
* Involvement of the permanent successor tooth crypt.
* Tooth requiring immediate extraction or not amenable to endodontic treatment.
* Compromised systemic health or uncontrolled chronic disease.
* Recent antibiotic use capable of affecting microbiological results.
* Noncooperative behavior that precluded safe clinical treatment.
Source: ClinicalTrials.gov (NCT02485210). StuddyBuddy aggregates publicly available trial information.