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Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct Treatment of Deep Carious Lesions in Children

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Antimicrobial photodynamic therapy (aPDT)
Without Antimicrobial phothodynamic therapy
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Photochemotherapy

Eligibility Criteria

3 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients included in the study should have at least one primary molar or permanent with deep active caries limited occlusal / proximal surfaces involving beyond the inner half of dentin.

Exclusion Criteria:

  • Children whose parents refuse to sign the informed consent document
  • Children who do not cooperate with the clinical examination/treatment
  • Children with syndromes or chronic systemic diseases
  • Teeth with painful symptoms consistent with irreversible pulpitis or mobility
  • Periodontal changes
  • Roots with pathological resorption
  • Cases of primary teeth roots in advanced stage of physiological resorption and patients that have made the use of any antibiotics during the study period or within three months prior to its beginning

Sites / Locations

  • Universidade Federal Fluminense

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Antimicrobial photodynamic therapy (aPDT)

Group without Antimicrobial photodynamic therapy (aPDT)

Arm Description

1)Selective caries removal: caries dentin was partially removed with hand excavators (Fava, Pirituba, Brazil). 2)The laser technique: 0.01% methylene blue solution was applied, and a pre-irradiation period of 5 minutes was done with an Indium Gallium Aluminum Phosphorus diode laser (InGaAlP) with a wavelength of 660 nm (visible red), a spot area of 3mm2, and fixed output power of 100 mW (energy of 9 J with 90 seconds). 3) The restorative technique was done as described in comparator group.

1) Selective caries removal 2) The restorative technique was done by etching with 37% CondacTM phosphoric acid conditioner (FGM) for 15 s in enamel and 7 s in dentin was performed followed by washing for 30 s until the conditioner was completely removed. The excess of dentin moisture was removed with sterile cotton balls, and the enamel was air-dried until it had an opaque appearance. Subsequently, two consecutive layers of Adper Single Bond 2TM (3M ESPE) were applied with a KG Brush (KG Sorensen) on the enamel and dentin for 15 s and subjected to light air blast to promote solvent evaporation. The adhesive was photoactivated for 10 s with a light-emitting diode (LED) unit (BioLuz Plus; BioArt) with an intensity of 460 mW/mm2. The cavity was restored with a Filtek Z250TM composite resin (3M Dental Products) according to the incremental technique. Each increment was photo-activated for 40 s.

Outcomes

Primary Outcome Measures

Evaluate Antimicrobial photodynamic therapy (aPDT) on microorganism reduction in deep cavities immediately after dental caries remotion and immediately use aPDT
Microorganisms reduction count after after manual excavation (control) and immediately after aPDT (experimental) obtained by means counting of colony forming units (CFU / mg of carious dentin), blindly from coded samples from the following viability of microorganisms total microorganisms; Candida genus; Streptococcus mutans; total Streptococcus; Lactobacillus spp. and for Enterococcus genus.After the period of 3, 6, 12 and 24 months of implementation of the treatment, there will be clinical and radiographic examination for treatment success.
Evaluation of composite restorations in primary molars subjected to selective caries removal associated with antimicrobial photodynamic therapy
Antimicrobial photodynamic therapy (aPDT) has been used as an adjunct treatment of deep caries lesions; however, studies on the effects of aPDT on the longevity of restorations are still limited.

Secondary Outcome Measures

Effect of Treatment with Selective Caries Removal Associated to Antimicrobial Photodynamic Therapy on Children's Oral HealthRelated Quality of Life: A Non-Randomized Clinical Study
How patients perceive impact of diseases is an essential component when characterising different disease impacts, and effects of dental treatments should be perceived by the patients.

Full Information

First Posted
September 1, 2016
Last Updated
November 27, 2022
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT02908789
Brief Title
Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct Treatment of Deep Carious Lesions in Children
Official Title
Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct Treatment for Deep Carious Lesions in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

5. Study Description

Brief Summary
This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) in deep carious lesions. This study was approved by the Research Ethics Committee and was conducted on 53 patients between 3 and 12 years. Patients included in the study should have at least one primary molar or permanent with deep active caries and limited occlusal/proximal surfaces involving beyond the inner half of dentin. The investigators considered from exclusion criteria children whose parents refuse to sign the informed consent document; children who do not cooperate with the clinical examination/treatment; children with syndromes or chronic systemic diseases; teeth with painful symptoms consistent with irreversible pulpitis or mobility; periodontal changes; roots with pathological resorption; cases of primary teeth roots in an advanced stage of physiological resorption and patients that have made the use of any antibiotics during the study period or within three months prior to its beginning. The treatments were carried out after local anesthesia and isolation of the operative field with a rubber dam. The removal of carious dentin surface demineralized necrotic and not subject to remineralization was held with the drill at low rpm under cooling with sterile saline. The removal of decayed tissue will start with the side walls and later on the pulp wall. After this time the intervention with aPDT using 0.01% methylene blue as photosensitizer will be held. Finally, the cavity is restored with an adhesive and composite resin system. To collect data for the first outcome the dentin samples were collected from 23 participants with the help of spoon sterile dentine in two stages: C1 after digging and C2 after aPDT. The microbiological analyzes will be conducted by counting colony-forming units (CFU / mg of carious dentin), blindly from coded samples. The viability of microorganisms will be evaluated in the following culture media: Brain Heart Infusion agar for the feasibility of total microorganisms; CHROMagar candida to Candida genus; Mitis Salaviarius agar with the addition of bacitracin 0.2 U/mL, sucrose and glucose to Streptococcus mutans; Mitis Salivarius agar to total Streptococcus; Rogosa Agar to Lactobacillus spp. and enterococcosel for Enterococcus genus. The reproducibility of the counting method will be verified between triplicates. Microbiological data will be evaluated with appropriate statistical tests with a level of 5%. For the second outcome, a randomized clinical trial was designed. Primary molars of 30 patients (mean age 6.15 years) with deep caries lesions without signs and symptoms of pulpal involvement were selected. A total of 64 teeth were randomly divided into groups G1 (SCR, 32 teeth) and G2 (SCR + aPDT, 32 teeth) for treatment, restored with composite and evaluated after a week (T0), 6 months (T1), and 12 months (T2) according to the criteria of FDI. Groups were compared using the Rao-Scott chi-squared test and the logistic regression analysis for complex designs to ac- count for multiple observations per subject (alpha = 0.05). All participants answered a questionaire to detect the impact on Oral Health-related quality of life(OHRQoL) before and 3 months after the treatment. Based on this project we prove the clinical efficacy of aPDT using 0.01% methylene blue as an adjunct in reducing microorganisms from the interior of deep carious lesions and we contributed to demonstrate the clinical and radiographic success in a follow-up from 12 months providing additional support aPDT used as an adjunct to SCR on the longevity of composite resin restorations in primary molars. A low laser therapy (aPDT) with SCR did not influence negatively OHRQoL. In the practice of pediatric dentistry, this conservative dental treatment improved the OHRQoL after 3 months of follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Photochemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antimicrobial photodynamic therapy (aPDT)
Arm Type
Experimental
Arm Description
1)Selective caries removal: caries dentin was partially removed with hand excavators (Fava, Pirituba, Brazil). 2)The laser technique: 0.01% methylene blue solution was applied, and a pre-irradiation period of 5 minutes was done with an Indium Gallium Aluminum Phosphorus diode laser (InGaAlP) with a wavelength of 660 nm (visible red), a spot area of 3mm2, and fixed output power of 100 mW (energy of 9 J with 90 seconds). 3) The restorative technique was done as described in comparator group.
Arm Title
Group without Antimicrobial photodynamic therapy (aPDT)
Arm Type
Sham Comparator
Arm Description
1) Selective caries removal 2) The restorative technique was done by etching with 37% CondacTM phosphoric acid conditioner (FGM) for 15 s in enamel and 7 s in dentin was performed followed by washing for 30 s until the conditioner was completely removed. The excess of dentin moisture was removed with sterile cotton balls, and the enamel was air-dried until it had an opaque appearance. Subsequently, two consecutive layers of Adper Single Bond 2TM (3M ESPE) were applied with a KG Brush (KG Sorensen) on the enamel and dentin for 15 s and subjected to light air blast to promote solvent evaporation. The adhesive was photoactivated for 10 s with a light-emitting diode (LED) unit (BioLuz Plus; BioArt) with an intensity of 460 mW/mm2. The cavity was restored with a Filtek Z250TM composite resin (3M Dental Products) according to the incremental technique. Each increment was photo-activated for 40 s.
Intervention Type
Radiation
Intervention Name(s)
Antimicrobial photodynamic therapy (aPDT)
Intervention Description
Selective caries removal + Antimicrobial photodynamic therapy (aPDT) is an effective low potency laser that involves the activation of a photosensitizer( 0.01% methylene blue ) by a visible light source that creates chemical reactions, producing cytotoxic reactive oxygen species and causing oxidative stress and inactivation of pathogenic microorganisms + tooth restauration
Intervention Type
Other
Intervention Name(s)
Without Antimicrobial phothodynamic therapy
Intervention Description
Selective caries removal + tooth restauration
Primary Outcome Measure Information:
Title
Evaluate Antimicrobial photodynamic therapy (aPDT) on microorganism reduction in deep cavities immediately after dental caries remotion and immediately use aPDT
Description
Microorganisms reduction count after after manual excavation (control) and immediately after aPDT (experimental) obtained by means counting of colony forming units (CFU / mg of carious dentin), blindly from coded samples from the following viability of microorganisms total microorganisms; Candida genus; Streptococcus mutans; total Streptococcus; Lactobacillus spp. and for Enterococcus genus.After the period of 3, 6, 12 and 24 months of implementation of the treatment, there will be clinical and radiographic examination for treatment success.
Time Frame
Microorganisms reduction couting of colony forming units will be evaluated seven days after. The clinical success will be evaluated 3 months, 6 months, 12 months and 24 months.
Title
Evaluation of composite restorations in primary molars subjected to selective caries removal associated with antimicrobial photodynamic therapy
Description
Antimicrobial photodynamic therapy (aPDT) has been used as an adjunct treatment of deep caries lesions; however, studies on the effects of aPDT on the longevity of restorations are still limited.
Time Frame
A total of 64 teeth were randomly divided into groups G1 (SCR, 32 teeth) and G2 (SCR + aPDT, 32 teeth) for treatment, restored with composite, and evaluated after a week (T0), 6 months (T1), and 12 months (T2) according to the criteria of FDI.
Secondary Outcome Measure Information:
Title
Effect of Treatment with Selective Caries Removal Associated to Antimicrobial Photodynamic Therapy on Children's Oral HealthRelated Quality of Life: A Non-Randomized Clinical Study
Description
How patients perceive impact of diseases is an essential component when characterising different disease impacts, and effects of dental treatments should be perceived by the patients.
Time Frame
The impact was assessed before and after conservative treatment of deep caries lesions using the selective caries removal (SCR) associated to a low laser therapy (antimicrobial photodynamic therapy-aPDT) on oral health-related quality of life (OHRQoL).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients included in the study should have at least one primary molar or permanent with deep active caries limited occlusal / proximal surfaces involving beyond the inner half of dentin. Exclusion Criteria: Children whose parents refuse to sign the informed consent document Children who do not cooperate with the clinical examination/treatment Children with syndromes or chronic systemic diseases Teeth with painful symptoms consistent with irreversible pulpitis or mobility Periodontal changes Roots with pathological resorption Cases of primary teeth roots in advanced stage of physiological resorption and patients that have made the use of any antibiotics during the study period or within three months prior to its beginning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia Antunes, PHD
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal Fluminense
City
Nova Friburgo
State/Province
Rio De Janeiro
ZIP/Postal Code
28625650
Country
Brazil

12. IPD Sharing Statement

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Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct Treatment of Deep Carious Lesions in Children

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