Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826810
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Molar Incisor Hypomineralization Radiation: aPDT Procedure: ART Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Clinical evaluations of complete removal of caries lesion, microbiological and radiographic analysis were made by two blind examiners, who did not know to which group the participants belonged.
Primary Purpose: Treatment
Official Title: Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH - Controlled Clinical Trial
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 30, 2018

Arm Intervention/treatment
Experimental: aPDT + ART group
In this group, both aPDT and ART were performed.
Radiation: aPDT
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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826810


Locations
Layout table for location information
Brazil
Faculdades Integradas Da União Educacional Do Planalto Central
Gama, DF, Brazil, 72445-020
Sponsors and Collaborators
University of Nove de Julho
Layout table for additonal information
Responsible Party: Sandra Kalil Bussadori, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03826810    
Other Study ID Numbers: Leticia
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Enamel Hypoplasia
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities