Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization

Molar Incisor Hypomineralization Clinical Trial

Official title:

Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization - a Randomized, Controlled, Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03904641
• Other study ID #: HMIaPDT
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2019
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Radiation:
• aPDT
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.

Procedure:
• ART
Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and immediately after treatment.
Secondary	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.	Baseline and immediately after treatment.
Secondary	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.	6 and 12 months.
Secondary	Change in clinical aspect	The retention of the material in the cavity and the presence of secondary caries will be evaluated.	6 and 12 months.