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Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization

Primary Purpose

Molar Incisor Hypomineralization

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
aPDT
ART
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

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

Inclusion Criteria:

  • Healthy children, without systemic alterations;
  • Collaborative children;
  • Present at least one permanent molar with active and acute caries lesion in dentin, not exceeding 2/3 and involving only the occlusal, with direct vision and access, without clinical and radiographic signs and symptoms of pulp involvement.

Exclusion Criteria:

  • Child with systemic impairment;
  • Non-cooperative behavior;
  • Carious lesion of Class II, III, IV or V type of Black;
  • Clinically: carious lesion involving enamel, deficient restorations, small carious lesions in dentin (without access to hand excavators), occult caries lesions, clinical sign and/or symptom of pulp involvement, clinical impossibility of restoration;
  • Radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3 of the dentin.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    aPDT + ART group

    ART group

    Arm Description

    In this group, both aPDT and ART will be performed.

    In this group, only ART will be performed.

    Outcomes

    Primary Outcome Measures

    Change in dentin sensitivity
    Prior to removal of carious tissue, the volunteers will respond to the Visual Analogue Scale (VAS), following this protocol: gauze isolation of neighboring teeth and air jet in the tooth with MIH for 3 to 5 seconds. The evaluation of the sensitivity through the VAS will be repeated at the end of the procedure, after Atraumatic Restorative Treatment (ART).

    Secondary Outcome Measures

    Change in colony forming units
    Microbiological specimens will be collected from the surface of the dentin before and immediately after the treatment, for later counting of colony forming units.
    Change in dentin density
    The objective is to quantitatively determine the gray tones of the affected dentin region just below the glass ionomer restoration, whose radiographic control for visualization of the healthy dentin allows the clinical evaluator of the study to compare the treated groups with the density of the remaining dentin in discussion. The statistical analysis of the optical density will be made according to the mixed effects model.
    Change in clinical aspect
    The retention of the material in the cavity and the presence of secondary caries will be evaluated.

    Full Information

    First Posted
    April 4, 2019
    Last Updated
    April 4, 2019
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03904641
    Brief Title
    Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization
    Official Title
    Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization - a Randomized, Controlled, Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2019 (Anticipated)
    Primary Completion Date
    July 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Molar Incisor Hypomineralization (MIH) is a change in the formation of dental enamel of systemic origin that affects at least one of the first four permanent molars and usually affects incisors. During the eruption, the affected surfaces tend to fracture, exposing the dentin, which causes excessive sensitivity in addition to making the region very susceptible to the appearance of carious lesions. The objective of this research will be to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) in permanent teeth with severe and sensitive MIH. The methodology will be based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided in two groups. The selected teeth should have MIH on the occlusal surface, indicated for clinical restorative treatment. In Group 1, aPDT will be applied for the treatment of infected dentin. Afterwards, the teeth will be restored with high viscosity glass ionomer cement. In Group 2, the removal of the softened dentin around the side walls of the cavity with sharp dentine curettes and posterior restoration with high viscosity glass ionomer cement will be carried out. All patients will have clinical and radiographic follow-up with a time interval of 6 and 12 months. The data obtained will be submitted to descriptive statistical analysis to evaluate the association of categorical variables. Chi-square test and Fisher's Exact test will be used, and to analyze the correlation between the continuous variables, Pearson correlation test will be applied. For the analysis of dentin density in the scanned radiographic images and the microbiological results for colony forming units, ANOVA and Kruskal-Wallis will be applied.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Molar Incisor Hypomineralization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Clinical evaluations of complete removal of caries lesion, microbiological and radiographic analysis will be made by two blind examiners, who will not know to which group the participants belong.
    Allocation
    Randomized
    Enrollment
    48 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    aPDT + ART group
    Arm Type
    Experimental
    Arm Description
    In this group, both aPDT and ART will be performed.
    Arm Title
    ART group
    Arm Type
    Experimental
    Arm Description
    In this group, only ART will be performed.
    Intervention Type
    Radiation
    Intervention Name(s)
    aPDT
    Intervention Description
    For aPDT, PapacarieMblue (Fórmula e Ação) will be used. It will be left for 5 minutes in the cavity. The carious tissue will be removed and the application of the PapacarieMblue will be repeated. The tissue will then be irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ.
    Intervention Type
    Procedure
    Intervention Name(s)
    ART
    Intervention Description
    Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.
    Primary Outcome Measure Information:
    Title
    Change in dentin sensitivity
    Description
    Prior to removal of carious tissue, the volunteers will respond to the Visual Analogue Scale (VAS), following this protocol: gauze isolation of neighboring teeth and air jet in the tooth with MIH for 3 to 5 seconds. The evaluation of the sensitivity through the VAS will be repeated at the end of the procedure, after Atraumatic Restorative Treatment (ART).
    Time Frame
    Baseline and immediately after treatment.
    Secondary Outcome Measure Information:
    Title
    Change in colony forming units
    Description
    Microbiological specimens will be collected from the surface of the dentin before and immediately after the treatment, for later counting of colony forming units.
    Time Frame
    Baseline and immediately after treatment.
    Title
    Change in dentin density
    Description
    The objective is to quantitatively determine the gray tones of the affected dentin region just below the glass ionomer restoration, whose radiographic control for visualization of the healthy dentin allows the clinical evaluator of the study to compare the treated groups with the density of the remaining dentin in discussion. The statistical analysis of the optical density will be made according to the mixed effects model.
    Time Frame
    6 and 12 months.
    Title
    Change in clinical aspect
    Description
    The retention of the material in the cavity and the presence of secondary caries will be evaluated.
    Time Frame
    6 and 12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy children, without systemic alterations; Collaborative children; Present at least one permanent molar with active and acute caries lesion in dentin, not exceeding 2/3 and involving only the occlusal, with direct vision and access, without clinical and radiographic signs and symptoms of pulp involvement. Exclusion Criteria: Child with systemic impairment; Non-cooperative behavior; Carious lesion of Class II, III, IV or V type of Black; Clinically: carious lesion involving enamel, deficient restorations, small carious lesions in dentin (without access to hand excavators), occult caries lesions, clinical sign and/or symptom of pulp involvement, clinical impossibility of restoration; Radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3 of the dentin.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31574879
    Citation
    Vieira LDS, Paschoal MAB, de Barros Motta P, Ferri EP, Ribeiro CDPV, Dos Santos-Pinto LAM, Motta LJ, Goncalves MLL, Horliana ACRT, Fernandes KPS, Ferrari RAM, Deana AM, Bussadori SK. Antimicrobial photodynamic therapy on teeth with molar incisor hypomineralization-controlled clinical trial. Medicine (Baltimore). 2019 Sep;98(39):e17355. doi: 10.1097/MD.0000000000017355.
    Results Reference
    derived

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    Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization

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