Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization

NCT03904641 | Unknown Phase 1

• 1 other identifier: HMIaPDT
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in colony forming units

  Baseline and immediately after treatment.

• Change in dentin density

  6 and 12 months.

• Change in clinical aspect

  6 and 12 months.

Study Arms (2)

aPDT + ART group

EXPERIMENTAL

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

Radiation: aPDT; Procedure: ART

ART group

EXPERIMENTAL

In this group, only ART will be performed.

Procedure: ART

Interventions

aPDT 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.

aPDT + ART group

ART PROCEDURE

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

ART group; aPDT + ART group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (1)

• 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.

  PMID: 31574879 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 5, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04