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Clinical Trials/NCT02479958
NCT02479958
Completed
Phase 1

A Randomized in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin

University of Sao Paulo0 sites58 target enrollmentMay 2011
ConditionsDental Caries

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Dental Caries
Sponsor
University of Sao Paulo
Enrollment
58
Primary Endpoint
Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Despite of the decline of dental caries, this disease is still common in polarized groups affecting children. Therefore, the aim of this randomized blind in vivo study was to compare the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. Thirty two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin lesion in deciduous molar and were divided in three groups: 1. Control - chlorhexidine and resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC. The patients were submitted to initial clinical and radiographic examination and demographic features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and radiographic follow up at 6 and 12 months after the treatments. The carious dentin was collected before and after each treatment and the number of Streptococcus mutans, Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and total bacteria were established by quantitative PCR.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
January 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carolina Steiner-Oliveira

PhD

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. They should also have at least one primary molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits.

Exclusion Criteria

  • Children whose parents refused to sign the informed consent document, who did not cooperate with the clinical exams, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.

Outcomes

Primary Outcomes

Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)

Time Frame: 15 days after dentin collection

Quantification of S. mutans, L. casei, F. nucleatum, A. rimae and total bacteria by PCR (Polymerase Chain Reaction)

Secondary Outcomes

  • Restoration Quality(12 months)
  • Tooth Pain(12 months)

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