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

NCT ID: NCT02479958

Last Updated: 2015-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: EXPERIMENTAL

Rubber dam isolation

Intervention Type: PROCEDURE

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

Tooth drying

Intervention Type: PROCEDURE

The tooth was dried with air jet.

Dentin wash with chlorhexidine 2%

Intervention Type: 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.

APDT 1

Group Type: EXPERIMENTAL

Rubber dam isolation

Intervention Type: PROCEDURE

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

Tooth drying

Intervention Type: PROCEDURE

The tooth was dried with air jet.

Antimicrobial Photodynamic Therapy 1

Intervention Type: 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 2

Group Type: EXPERIMENTAL

Rubber dam isolation

Intervention Type: PROCEDURE

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

Tooth drying

Intervention Type: PROCEDURE

The tooth was dried with air jet.

Antimicrobial Photodynamic Therapy 2

Intervention Type: 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.

Interventions

Rubber dam isolation

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

Intervention Type: PROCEDURE

Tooth drying

The tooth was dried with air jet.

Intervention Type: PROCEDURE

Dentin wash with chlorhexidine 2%

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.

Intervention Type: PROCEDURE

Antimicrobial Photodynamic Therapy 1

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.

Intervention Type: PROCEDURE

Antimicrobial Photodynamic Therapy 2

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Carolina Steiner-Oliveira

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

150/10

Identifier Type: -

Identifier Source: org_study_id