Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-10-31

Brief Summary

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The aim of the proposed study is to assess the clinical effect of photodynamic therapy (PDT) on dentin with carious lesions in primary teeth. Patients with primary molars exhibiting deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to three groups: Group 1 - traditional caries removal with a low-speed drill; Group 2 - PDT + PapaMblue (carious tissue removal agent) modified with methylene blue; and Group 3 - PDT with methylene blue 0.05%. PDT will be performed with low-level laser for the treatment of the carious tissue. Dentin samples will be removed before and after PDT for microbiological analysis. The microbiological samples will be cultured in Brucella blood agar, Mitis Salibarius-bacitracin agar and Rogosa SL agar. The teeth will then be restored using high-viscosity glass ionomer cement, with clinical and radiographic follow up at six, 12 and 24 months. The data will be submitted to descriptive statistics.

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Detailed Description

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The groups of study (Group 1)- Conventional caries removal with low-speed drill (Group 2)- PDT combined with PapaMblue (Group 3)- PDT combined with methylene blue

The data in descriptive statistics will be used The chi-squared test and Fisher's exact test will be used for the comparison of categorical variables (age and gender). The Student's t-test and analysis of variance will be used for the comparison of signs and symptoms of reversible pulpitis. Pearson's correlation coefficients will be calculated to determine the strength of correlations among the continuous variables.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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PapacarieMBlue and PDT

Initial periapical and interproximal radiographs; Microbiological sample with otoscope curette to standardize volume of carious tissue; Application on PapacarieMBlue (addition of toluidine blue) for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with non-cutting curette; No removal of carious tissue on pulp floor; Irradiation of dental tissue for one minute on a single point; Second microbiological sample of remaining dentin with curette; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); Follow up: Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.

Group Type EXPERIMENTAL

PapacarieMBlue and PDT

Intervention Type DRUG

Initial periapical and interproximal radiographs Microbiological sample with otoscope curette to standardize volume of carious tissue; Application on PapacarieMBlue (addition of toluidine blue) for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with non-cutting curette; No removal of carious tissue on pulp floor; Irradiation of dental tissue for one minute on a single point; Second microbiological sample of remaining dentin with curette; Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.

Laser

Intervention Type DEVICE

Toluidine Blue O and PDT

Initial periapical and interproximal radiographs;Microbiological sample with otoscope curette to standardize volume of carious tissue;Application of Toluidine Blue O for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with sharp curette; No removal of carious tissue on pulp floor;non-cutting curette; Irradiation of dental tissue for one minute on a single point;Second microbiological sample of remaining dentin with curette; Follow up; Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.

Group Type EXPERIMENTAL

Toluidine Blue O and PDT

Intervention Type DRUG

Initial periapical and interproximal radiographs;Microbiological sample with otoscope curette to standardize volume of carious tissue;Application of Toluidine Blue O for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with sharp curette; No removal of carious tissue on pulp floor;non-cutting curette; Irradiation of dental tissue for one minute on a single point;Second microbiological sample of remaining dentin with curette;Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE);Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.

Laser

Intervention Type DEVICE

Interventions

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PapacarieMBlue and PDT

Initial periapical and interproximal radiographs Microbiological sample with otoscope curette to standardize volume of carious tissue; Application on PapacarieMBlue (addition of toluidine blue) for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with non-cutting curette; No removal of carious tissue on pulp floor; Irradiation of dental tissue for one minute on a single point; Second microbiological sample of remaining dentin with curette; Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.

Intervention Type DRUG

Toluidine Blue O and PDT

Initial periapical and interproximal radiographs;Microbiological sample with otoscope curette to standardize volume of carious tissue;Application of Toluidine Blue O for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with sharp curette; No removal of carious tissue on pulp floor;non-cutting curette; Irradiation of dental tissue for one minute on a single point;Second microbiological sample of remaining dentin with curette;Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE);Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.

Intervention Type DRUG

Laser

Intervention Type DEVICE

Other Intervention Names

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Photodynamic therapy and lower level laser therapy Photodynamic therapy and lower level laser therapy

Eligibility Criteria

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Inclusion Criteria

Adequate health, with no systemic conditions; Cooperative behavior; Presence of at least one primary molar with acute, active carious lesion not surpassing 2/3 of the dentin and only involving the occlusal face, with direct view and access and no clinical or radiographic signs of pulp involvement

Exclusion Criteria

Systemic condition; Uncooperative behavior; Class II, III, IV or V carious lesion (Black's classification); Clinical evidence of carious lesion involving enamel, deficient restorations, insufficient size of carious lesion on dentin for access to dental instrument, hidden carious lesions, sign or symptom of pulp involvement, clinical impossibility of restoration; Radiographic evidence of pulp involvement; carious lesion surpassing 2/3 of dentin.

Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes