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

Summary

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.

Conditions

• Dental Caries

Interventions

DRUG

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.

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.

DEVICE

Laser

Sponsors & Collaborators

• University of Nove de Julho

  lead OTHER

Principal Investigators

• Sandra K Bussadori, Dentist · University of Nove de Julho

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

11 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2016-10-31

Completion

2016-10-31

Countries

• Brazil

Study Locations