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

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
PapacarieMBlue and PDT
Toluidine Blue O and PDT
Laser
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, PDT, LLLT, pediatric dentistry

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Nove de JulhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PapacarieMBlue and PDT

Toluidine Blue O and PDT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Microbiological analysis - collection of dentinal tissue and restoration with glass ionomer cement
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

Radiographs evaluation
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.

Full Information

First Posted
September 13, 2013
Last Updated
April 11, 2016
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02734420
Brief Title
Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial
Official Title
Effect of Photodynamic Therapy With Low-level Laser on Infected Dentin in Primary Teeth: A Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries, PDT, LLLT, pediatric dentistry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PapacarieMBlue and PDT
Arm Type
Experimental
Arm Description
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.
Arm Title
Toluidine Blue O and PDT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PapacarieMBlue and PDT
Other Intervention Name(s)
Photodynamic therapy and lower level laser therapy
Intervention Description
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
Intervention Name(s)
Toluidine Blue O and PDT
Other Intervention Name(s)
Photodynamic therapy and lower level laser therapy
Intervention Description
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
Device
Intervention Name(s)
Laser
Primary Outcome Measure Information:
Title
Microbiological analysis - collection of dentinal tissue and restoration with glass ionomer cement
Description
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.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Radiographs evaluation
Description
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.
Time Frame
up to 24 mounth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zenildo S Junior, Dentist
Phone
0055 11949759639
Email
zenildo-junior@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra K Bussadori, Dentist
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Nove de Julho
City
São Paulo
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra K Bussadori, Dentist
Phone
0055 11983817453
Email
sandra.skb@gmail.com
First Name & Middle Initial & Last Name & Degree
Zenildo S Silva Junior, DDS, MsC

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30985667
Citation
Costa-Santos L, Silva-Junior ZS, Sfalcin RA, Mota ACCD, Horliana ACRT, Motta LJ, Mesquita-Ferrari RA, Fernandes KPS, Prates RA, Silva DFT, Deana A, Bussadori SK. The effect of antimicrobial photodynamic therapy on infected dentin in primary teeth: A randomized controlled clinical trial protocol. Medicine (Baltimore). 2019 Apr;98(15):e15110. doi: 10.1097/MD.0000000000015110.
Results Reference
derived
Links:
URL
http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisa.jsf
Description
Estudo clínico controlado do efeito da terapia fotodinâmica com laser de baixa potência em dentina infectada de dentes decíduos.

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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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