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

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ClinicalTrials.gov Identifier: NCT02479958
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 25, 2015
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Carolina Steiner-Oliveira, 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.

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: Rubber dam isolation Procedure: Tooth drying Procedure: Dentin wash with chlorhexidine 2% Procedure: Antimicrobial Photodynamic Therapy 1 Procedure: Antimicrobial Photodynamic Therapy 2 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
Study Start Date : May 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control Procedure: Rubber dam isolation
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples

Procedure: Tooth drying
The tooth was dried with air jet.

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.

Experimental: APDT 1 Procedure: Rubber dam isolation
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples

Procedure: Tooth drying
The tooth was dried with air jet.

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.

Experimental: APDT 2 Procedure: Rubber dam isolation
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples

Procedure: Tooth drying
The tooth was dried with air jet.

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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Tooth Pain [ Time Frame: 6 months ]
    Patients reported the presence or absence of tooth pain after 6 months

  2. Tooth Pain [ Time Frame: 12 months ]
    Patients reported the presence or absence of tooth pain after 6 months

  3. Restoration Quality [ Time Frame: 6 months ]
    The quality of restoration was evaluated through the absence of radiographic radiolucent area after 6 months

  4. Restoration Quality [ Time Frame: 12 months ]
    The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months



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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Carolina Steiner-Oliveira, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02479958     History of Changes
Other Study ID Numbers: 150/10
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015
Keywords provided by Carolina Steiner-Oliveira, University of Sao Paulo:
Photochemotherapy
Bacteria
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents