Antimicrobial Photodynamic Therapy on Teeth With Molar Incisor Hypomineralization

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

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.

Study Overview

• Status: Unknown
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Radiation: aPDT; Procedure: ART

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: aPDT + ART group; In this group, both aPDT and ART will be performed.	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.
EXPERIMENTAL: ART group; In this group, only ART will be performed.	Procedure: ART; Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (ACTUAL): April 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia
• Other Study ID Numbers: HMIaPDT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No