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

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ClinicalTrials.gov Identifier: NCT02734420
Recruitment Status : Unknown
Verified April 2016 by Zenildo Santos Silva Jr., D.D.S, M.Sc.Ph.D, University of Nove de Julho.
Recruitment status was:  Recruiting
First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Zenildo Santos Silva Jr., D.D.S, M.Sc.Ph.D, University of Nove de Julho

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Caries Drug: PapacarieMBlue and PDT Drug: Toluidine Blue O and PDT Device: Laser Phase 1

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial
Study Start Date : September 2013
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Photodynamic therapy and lower level laser therapy

Device: Laser
Experimental: 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.
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.
Other Name: Photodynamic therapy and lower level laser therapy

Device: Laser



Primary Outcome Measures :
  1. Microbiological analysis - collection of dentinal tissue and restoration with glass ionomer cement [ Time Frame: 24 months ]
    Based on a study by Guglielmi et al. (2011)(30) teeth with be selected (n = 48) and divided into three groups, as delineated in Chart 4. Fragments of dentinal tissue will be collected from all teeth before and after treatment for microbiological analysis. The teeth will be restored with glass ionomer cement in all cases.


Secondary Outcome Measures :
  1. Radiographs evaluation [ Time Frame: up to 24 mounth ]
    Radiographic subtraction and the evaluation of the density of the remaining dentin will be performed prior to and following treatment for the removal of carious tissue as well as at six, 12 and 24 months after treatment. Periapical radiographs will be performed initially to include or exclude teeth based on the eligibility criteria. Immediately following the clinical procedure, the first bitewing radiograph will be taken. Bitewing x-rays will also be taken during the three follow up sessions.The bitewing x-rays will be standardized using a positioner. A portion of self-curing acrylic resin will be placed on the surface of the tooth to be evaluated and its antagonist for the impression of the surface anatomy and adapted to the positioner. This will allow the same positioning of the film during the different evaluations as well as the standardization of the x-rays at the same vertical and horizontal angles and distance for all radiographs taken with the same patient.



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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734420


Contacts
Contact: Zenildo S Junior, Dentist 0055 11949759639 zenildo-junior@hotmail.com

Locations
Brazil
Universidade Nove de Julho Recruiting
São Paulo, Brazil, 01504-001
Contact: Sandra K Bussadori, Dentist    0055 11983817453    sandra.skb@gmail.com   
Principal Investigator: Zenildo S Silva Junior, DDS, MsC         
Sponsors and Collaborators
University of Nove de Julho
Investigators
Study Director: Sandra K Bussadori, Dentist University of Nove de Julho

Additional Information:
Responsible Party: Zenildo Santos Silva Jr., D.D.S, M.Sc.Ph.D, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02734420     History of Changes
Other Study ID Numbers: ZENILDOJUNIOR
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zenildo Santos Silva Jr., D.D.S, M.Sc.Ph.D, University of Nove de Julho:
Dental caries
PDT
LLLT
pediatric dentistry

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Tolonium Chloride
Hemostatics
Coagulants
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action