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NCT Number: NCT03826810

Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH

The objective of this research was to evaluate the clinical effect of photodynamic therapy on dentin infected by caries lesion in permanent teeth with Molar Incisor Hypomineralization (MIH). The study was composed of Groups (1 and 2). The methodology was based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided. The selected teeth had deep dentin caries lesions on the occlusal surface, and sensitivity, indicated for clinical restorative treatment. Photodynamic therapy was applied with the use of low-intensity laser in permanent teeth selected for the treatment of infected dentin in G1. In this group, antimicrobial photodynamic therapy (aPDT) and atraumatic restorative treatment (ART) were made. In G2, only ART was performed. The teeth were restored with high viscosity glass ionomer cement. All patients had clinical and radiographic follow-up with a time interval of 6 and 12 months. Data were submitted to descriptive statistical analysis. For the evaluation of the association of categorical variables like age and gender, the Chi-square test and Fisher's exact test were used. To analyze the correlation between the continuous variables, the Pearson correlation test was applied. ANOVA and Kruskal-Wallis were applied for the analysis of dentin density in the radiographic images scanned and the microbiological results for colony forming units.

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Key information

Conditions

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

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Faculdades Integradas Da União Educacional Do Planalto Central

Gama, Federal District, 72445-020, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aPDT

Radiation

For the aPDT the PapacarieMblue (Fórmula e Ação) was used. It was left for 5 minutes in the cavity. The carious tissue was removed and the application of the PapacarieMblue was repeated. The tissue was then irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ. These parameters were also applied in the vestibular root of the teeth, to try and prevent sensitivity.

ART

Procedure

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

Primary outcomes

  1. Change in dentin sensitivity

    Time frame: Before and immediately after treatment.

    Prior to removal of carious tissue, the volunteers responded 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 was repeated at the end of the procedure, after Atraumatic Restorative Treatment (ART).

Secondary outcomes

  1. Change in colony forming units

    Time frame: Before and immediately after treatment.

    Microbiological specimens were collected from the surface of the dentin before and immediately after the treatment, for later counting of colony forming units.

  2. Change in dentin density

    Time frame: After 6 and 12 months.

    The objective was 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 were made according to the mixed effects model.

  3. Change in the presence of cavity filling

    Time frame: After 6 and 12 months.

    The evaluation scores will be evaluated based on the results of studies by other authors (Frencken, et al., 1996). Digital photos (Canon Sx500 IS Camera) will be taken of all the teeth and, from these photographs, the teeth will be classified as follows:

    0 = present, without defect.

    • = present, small defects in the margin less than 0.5 mm deep, no need for repair.
    • = present, small defects in the margin of 0.5 to 1 mm depth, needs repair.
    • = present, gross defects in the margin of 1 mm or more in depth, needs repair.
    • = absent, restoration almost / completely lost, needs treatment.
    • = absent, other treatment was performed for any other reason.
    • = tooth missing due to any reason.
    • = present, surface wear less than 0.5 mm, no need for replacement.
    • = present, surface wear greater than 0.5 mm, need replacement.
    • = impossible to diagnose.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH - Controlled Clinical Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2019
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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