An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Rubber dam isolation
Tooth drying
Dentin wash with chlorhexidine 2%
Antimicrobial Photodynamic Therapy 1
Antimicrobial Photodynamic Therapy 2
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Photochemotherapy, Bacteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control
APDT 1
APDT 2
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Tooth Pain
Patients reported the presence or absence of tooth pain after 6 months
Tooth Pain
Patients reported the presence or absence of tooth pain after 6 months
Restoration Quality
The quality of restoration was evaluated through the absence of radiographic radiolucent area after 6 months
Restoration Quality
The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months
Full Information
NCT ID
NCT02479958
First Posted
May 25, 2015
Last Updated
June 24, 2015
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02479958
Brief Title
An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
Official Title
A Randomized in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Photochemotherapy, Bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Title
APDT 1
Arm Type
Experimental
Arm Title
APDT 2
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Rubber dam isolation
Intervention Description
Tooth was isolated using a rubber dam isolation in order to collect the dentin samples
Intervention Type
Procedure
Intervention Name(s)
Tooth drying
Intervention Description
The tooth was dried with air jet.
Intervention Type
Procedure
Intervention Name(s)
Dentin wash with chlorhexidine 2%
Intervention Description
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
Intervention Name(s)
Antimicrobial Photodynamic Therapy 1
Intervention Description
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
Intervention Name(s)
Antimicrobial Photodynamic Therapy 2
Intervention Description
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 Measure Information:
Title
Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)
Description
Quantification of S. mutans, L. casei, F. nucleatum, A. rimae and total bacteria by PCR (Polymerase Chain Reaction)
Time Frame
15 days after dentin collection
Secondary Outcome Measure Information:
Title
Tooth Pain
Description
Patients reported the presence or absence of tooth pain after 6 months
Time Frame
6 months
Title
Tooth Pain
Description
Patients reported the presence or absence of tooth pain after 6 months
Time Frame
12 months
Title
Restoration Quality
Description
The quality of restoration was evaluated through the absence of radiographic radiolucent area after 6 months
Time Frame
6 months
Title
Restoration Quality
Description
The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Learn more about this trial
An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
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