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

NCT02479958 | Completed Phase 1

• 1 other identifier: 150/10
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Keywords

Photochemotherapy; Bacteria

Outcome Measures

Primary Outcomes (1)

• Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)

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

  15 days after dentin collection

Secondary Outcomes (4)

• Tooth Pain

  6 months

• Tooth Pain

  12 months

• Restoration Quality

  6 months

• Restoration Quality

  12 months

Study Arms (3)

Control

EXPERIMENTAL

Procedure: Rubber dam isolation; Procedure: Tooth drying; Procedure: Dentin wash with chlorhexidine 2%

APDT 1

EXPERIMENTAL

Procedure: Rubber dam isolation; Procedure: Tooth drying; Procedure: Antimicrobial Photodynamic Therapy 1

APDT 2

EXPERIMENTAL

Procedure: Rubber dam isolation; Procedure: Tooth drying; Procedure: Antimicrobial Photodynamic Therapy 2

Interventions

Rubber dam isolation PROCEDURE

Tooth was isolated using a rubber dam isolation in order to collect the dentin samples

APDT 1; APDT 2; Control

Tooth drying PROCEDURE

The tooth was dried with air jet.

APDT 1; APDT 2; Control

Dentin wash with chlorhexidine 2% PROCEDURE

Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a micropunch (Ø = 1mm) was performed. The remaining dentin was washed with chlorhexidine 2%. After that a a new dentin collection was performed at another site of the cavity, and restoration with resin-modified glass ionomer cement was placed.

Control

Antimicrobial Photodynamic Therapy 1 PROCEDURE

Partial carious tissue was removed with conventional dentine curette and collection of dentin with a micropunch (Ø = 1mm) was performed. The remaining dentin was washed with 200 µL of O-Toluidine blue dye (0.1 mg/mL) for 60 s. After this, a red LED light source with wavelength of 630 nm was used at 100 mW power, 9.0 J of energy, for 60 s with energy density of 30.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement Vitremer was placed.

APDT 1

Antimicrobial Photodynamic Therapy 2 PROCEDURE

Partial carious tissue was removed with conventional dentine curette and initial collection of dentin with a micropunch (Ø = 1mm) was performed. Treatment of the remaining dentin was performed with 200 µL of methylene blue dye 0.01% for 5 min and after this, a red low level LASER light source with wavelength of 660 nm was used at 100 mW power, 9.0 J of energy, for 90 s with energy density of 320.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement was placed.

APDT 2

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: June 24, 2015
• Study Start: May 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2014
• Last Updated: June 25, 2015

Record last verified: 2015-06