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
About this trial
This is an interventional treatment trial for Molar Incisor Hypomineralization
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.
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
NCT ID
NCT03904641
First Posted
April 4, 2019
Last Updated
April 4, 2019
Sponsor
University of Nove de Julho
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
Learn more about this trial
Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization
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