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| Name | Class |
|---|---|
| October University for Modern Sciences and Arts | OTHER |
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The controlled clinical trial will be done to evaluate Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish as minimally invasive techniques for management of enamel opacities of patients with molar incisor hypomineralization. Variation in mineral density of the enamel opacity , ,Hypersensitivity, Color change of the enamel opacity, Quality of life of the patient, Parent Satisfaction will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
A total of 75 patients will be selected according to the eligibility criteria from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University.
A Full detailed medical and dental history will be obtained from the parent and a clinical examination will be performed using a dental mirror and a dental explorer under LED illumination and after dryness of the teeth to make sure that the patients fulfill the inclusion criteria.
After explaining the aim of the study, benefits, possible risks and rights to the patients and their parents. A signed informed consent of the parents as well as child's assent, outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained prior to the conduction of the study. • The patients will be randomly equally allocated into three treatment groups (25 patients/ group): Group (A): patients will receive resin infiltration. Group (B): patients will receive resin modified glass ionomer varnish. Group (C): patients will receive a light cured giomer varnish.
Pre-operative procedures:
Clinical procedures
- All teeth will be cleaned using prophylaxis paste and brush.
Group A:
Group B:
Group C:
One drop of the active of the material will be mixed with one container of the base using a disposable brush.
A thin layer of the mixture will be applied on the affected enamel surface after drying and it will be left undistributed for three seconds
The material will be light cured for 10 seconds.
The patient will be followed at 1, 3,6,12 and 18 months for evaluation of:
Statistical Analysis All data will be tabulated, summarized and statistically analyzed using software SPSS (Statistical Packages for Social Sciences).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Resin infiltration |
|
| Group B | Experimental | Resin modified glass ionomer varnish |
|
| Group C | Experimental | Light cured giomer varnish |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin infiltration | Drug | Icon Resin Infiltration as minimally invasive technique |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Variation in mineral density | Variation in mineral density of the enamel opacity using laser fluorescence. | It will be evaluated preoperatively and at 1, 3,6,12 and 18 months follow up. |
| Hypersensitivity | Hypersensitivity using VAS scale | It will be evaluated pre operative and at 1, 3,6,12 and 18 months follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Color change of the enamel opacity | Color change of the enamel opacity using Vita easy shade | It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up. |
| Quality of life of the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hagar M Mohie | Contact | 0020100509369 | hmohie@msa.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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| Resin modified glass ionomer varnish |
| Drug |
Resin modified glass ionomer varnish as minimally invasive technique |
|
| Light cured giomer varnish | Drug | Light cured giomer varnish as minimally invasive technique |
|
Quality of life of the patient using Child Perceptions Questionnaire (CPQ)
| It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up. |
| Parent Satisfaction | Parent Satisfaction using Parental-Caregivers Perceptions Questionnaire (P- CPQ ) | It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up. |
| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| C000721947 | enamel opacities |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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