Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization

NCT ID: NCT03904641

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-12-01

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.

Conditions

Molar Incisor Hypomineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aPDT + ART group

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

Group Type: EXPERIMENTAL

aPDT

Intervention Type: RADIATION

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.

ART

Intervention Type: PROCEDURE

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

ART group

In this group, only ART will be performed.

Group Type: EXPERIMENTAL

ART

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: RADIATION

ART

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31574879 (View on PubMed)

Other Identifiers

HMIaPDT

Identifier Type: -

Identifier Source: org_study_id