An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin

Phase 1

Completed

• Conditions: Dental Caries
• Interventions: Procedure: Rubber dam isolation; Procedure: Tooth drying; Procedure: Antimicrobial Photodynamic Therapy 1; Procedure: Dentin wash with chlorhexidine 2%; Procedure: Antimicrobial Photodynamic Therapy 2

• Registration Number: NCT02479958
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-07
• Study Completion: 2014-01
• Study First Submitted: 2015-05-25
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-20
• Study First Posted: 2015-06-24
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Tooth drying	-
APDT 1	Rubber dam isolation	-
APDT 1	Antimicrobial Photodynamic Therapy 1	-
APDT 2	Rubber dam isolation	-
Control	Rubber dam isolation	-
Control	Dentin wash with chlorhexidine 2%	-
APDT 1	Tooth drying	-
APDT 2	Antimicrobial Photodynamic Therapy 2	-
APDT 2	Tooth drying	-

Primary Outcome Measures

Name	Time	Method
Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)	15 days after dentin collection	Quantification of S. mutans, L. casei, F. nucleatum, A. rimae and total bacteria by PCR (Polymerase Chain Reaction)

Secondary Outcome Measures

Name	Time	Method
Tooth Pain	12 months	Patients reported the presence or absence of tooth pain after 6 months
Restoration Quality	12 months	The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months