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Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities

Primary Purpose

Children, Adult, Molar Incisor Hypomineralization, Dental Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
white defects
yellow defects
brown defects
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children, Adult

Eligibility Criteria

9 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

. Pediatric patients, aged between 9 and 16 years.

  • Patients who have molar incisor hypomineralization, any lesion with isolated opacities or discoloration of the permanent incisors.
  • Patients who present at least one opacity in the central incisors.
  • Go to the dental clinic for revision or treatment of the University of Valencia.

Exclusion Criteria:

  • Opacities with loss of enamel or tooth structure, active caries lesions, clinical symptoms of irreversible pulpitis such as spontaneous pain or persistent pain, a history of using bleaching agents, with intolerance to any milk protein, who have an allergic pathology or syndromic or uncooperative during the clinical procedure.

Sites / Locations

  • Universitat de ValènciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

white defects

yellow defects

Brown defects

Arm Description

Evaluate the infiltration of the defects.

Evaluate the infiltration of the defects.

Evaluate the infiltration of the defects.

Outcomes

Primary Outcome Measures

Change in the color of opacities
Measured in color changes of opacities using the CIE L*A*B* system. The color of (coated) objects is visualized and quantified by using the CIELAB color space. The 3-dimensional color space is built-up from three axes that are perpendicular to one another.The L*-axis gives the lightness: a white object has an L* value of 100 and the L* value of a black object is 0. The so-called achromatic colors, the shades of grey, are on the L*-axis. Chromatic ('real') colors are described by using the two axes in the horizontal plane. The a*-axis is the green-red axis and the b*-axis goes from blue (-b*) to yellow (+b*).its measurement is possible thanks to the spectrophotometer. Clinical improvement and better visual perception of infiltrated enamel defects
Change in the density of opacities
DIAGNOdent is a diagnostic method based on an intermittent red fluorescence laser with a wavelength of 655 nm and 1 mW (milliwatt )that penetrates several millimeters from the tooth surface.

Secondary Outcome Measures

aesthetic change of opacities
Satisfaction questionnaire. A post-treatment questionnaire will be passed with questions regarding the satisfaction of the patient and parents. The results will be classified from 0 to 4, with 0 being not at all satisfied and 4 being very satisfied.

Full Information

First Posted
October 20, 2022
Last Updated
October 25, 2022
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05597956
Brief Title
Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities
Official Title
Effectiveness of Infiltration Resins in the Treatment of Enamel Defects in Child Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Enamel development defects are the result of a set of environmental, systemic and genetic causal agents that reveal a multifactorial etiology model, which in anterior teeth produces a serious aesthetic problem, converted into a problem of visual perception. In hypomineralized enamel, light rays encounter multiple interfaces between organic and mineral fluids, with different refractive indices. At each interface, the light is deflected and reflected, producing an overexposed "optical labyrinth" that is perceived as a yellow, white, or brown stain. The term "infiltration" has been modified and developed commercially in Germany for the treatment of non-cavitated caries on smooth and proximal surfaces, in which the porosities of the enamel lesion are infiltrated with a low-viscosity resin, thus creating a barrier of diffusion, without the need for any type of additional material on the tooth surface. An added positive effect of infiltration with the queens is that the enamel lesions lose their whitish appearance when the microporosities are filled, mimicking the area of the lesion with the remaining healthy enamel. This effect is what has led clinicians to adapt this treatment for the management of enamel defects. Given the growing interest in the treatment of opacities in the anterior sector, due to the demanding contemporary aesthetic requirements, and the increased acceptance of minimally invasive therapies, the need has been seen to seek greater predictability for the treatment of defects. of conservative enamel from an early age and offer effective therapeutic alternatives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Adult, Molar Incisor Hypomineralization, Dental Diseases, Opacity, Anterior Teeth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
white defects
Arm Type
Experimental
Arm Description
Evaluate the infiltration of the defects.
Arm Title
yellow defects
Arm Type
Experimental
Arm Description
Evaluate the infiltration of the defects.
Arm Title
Brown defects
Arm Type
Experimental
Arm Description
Evaluate the infiltration of the defects.
Intervention Type
Procedure
Intervention Name(s)
white defects
Intervention Description
"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".
Intervention Type
Procedure
Intervention Name(s)
yellow defects
Intervention Description
"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".
Intervention Type
Procedure
Intervention Name(s)
brown defects
Intervention Description
"With the previously cleaned tooth, the enamel will be prepared with a product that makes it more porous, thus eliminating the decalcified areas of the deepest part of the lesion. After completely removing the water from the surface, the resin will be applied infiltrating between the canaliculi of the enamel. When polymerized, it will form a framework that will seal the surface, thus improving surface resistance and aesthetics by modifying the refractive indices of the affected enamel, mimicking it with the remaining healthy enamel".
Primary Outcome Measure Information:
Title
Change in the color of opacities
Description
Measured in color changes of opacities using the CIE L*A*B* system. The color of (coated) objects is visualized and quantified by using the CIELAB color space. The 3-dimensional color space is built-up from three axes that are perpendicular to one another.The L*-axis gives the lightness: a white object has an L* value of 100 and the L* value of a black object is 0. The so-called achromatic colors, the shades of grey, are on the L*-axis. Chromatic ('real') colors are described by using the two axes in the horizontal plane. The a*-axis is the green-red axis and the b*-axis goes from blue (-b*) to yellow (+b*).its measurement is possible thanks to the spectrophotometer. Clinical improvement and better visual perception of infiltrated enamel defects
Time Frame
Between five and six months
Title
Change in the density of opacities
Description
DIAGNOdent is a diagnostic method based on an intermittent red fluorescence laser with a wavelength of 655 nm and 1 mW (milliwatt )that penetrates several millimeters from the tooth surface.
Time Frame
Between five and six months
Secondary Outcome Measure Information:
Title
aesthetic change of opacities
Description
Satisfaction questionnaire. A post-treatment questionnaire will be passed with questions regarding the satisfaction of the patient and parents. The results will be classified from 0 to 4, with 0 being not at all satisfied and 4 being very satisfied.
Time Frame
Between five and six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: . Pediatric patients, aged between 9 and 16 years. Patients who have molar incisor hypomineralization, any lesion with isolated opacities or discoloration of the permanent incisors. Patients who present at least one opacity in the central incisors. Go to the dental clinic for revision or treatment of the University of Valencia. Exclusion Criteria: Opacities with loss of enamel or tooth structure, active caries lesions, clinical symptoms of irreversible pulpitis such as spontaneous pain or persistent pain, a history of using bleaching agents, with intolerance to any milk protein, who have an allergic pathology or syndromic or uncooperative during the clinical procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Dolores Casaña Ruiz, Mrs
Phone
678947337
Ext
+34
Email
dolo_1995@hotmail.com
Facility Information:
Facility Name
Universitat de València
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MªDolores Casaña-Ruiz
Phone
678947337
Ext
+34
Email
dolo_1995@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The project will be carried out by a research team. Where there will be a principal investigator, and a collaborator who will carry out the clinical experimentation part.

Learn more about this trial

Effectiveness of Infiltration With Resin in Treatment of MIH Incisors in Children Showing Opacities

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