Overview

Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial

Status:
Unknown status
Trial end date:
2016-10-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the proposed study is to assess the clinical effect of photodynamic therapy (PDT) on dentin with carious lesions in primary teeth. Patients with primary molars exhibiting deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to three groups: Group 1 - traditional caries removal with a low-speed drill; Group 2 - PDT + PapaMblue (carious tissue removal agent) modified with methylene blue; and Group 3 - PDT with methylene blue 0.05%. PDT will be performed with low-level laser for the treatment of the carious tissue. Dentin samples will be removed before and after PDT for microbiological analysis. The microbiological samples will be cultured in Brucella blood agar, Mitis Salibarius-bacitracin agar and Rogosa SL agar. The teeth will then be restored using high-viscosity glass ionomer cement, with clinical and radiographic follow up at six, 12 and 24 months. The data will be submitted to descriptive statistics.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Nove de Julho
Treatments:
Tolonium Chloride
Criteria
Inclusion Criteria:

Adequate health, with no systemic conditions; Cooperative behavior; Presence of at least
one primary molar with acute, active carious lesion not surpassing 2/3 of the dentin and
only involving the occlusal face, with direct view and access and no clinical or
radiographic signs of pulp involvement

Exclusion Criteria:

Systemic condition; Uncooperative behavior; Class II, III, IV or V carious lesion (Black's
classification); Clinical evidence of carious lesion involving enamel, deficient
restorations, insufficient size of carious lesion on dentin for access to dental
instrument, hidden carious lesions, sign or symptom of pulp involvement, clinical
impossibility of restoration; Radiographic evidence of pulp involvement; carious lesion
surpassing 2/3 of dentin.