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The goal of this clinical trial is to examine the clinical success of different pre-treatments in resin infiltration therapy applied to the incisors of pediatric patients with Molar Incisor Hypomineralization (MIH) and to evaluate the impact of treatment on the quality of life of children. The main questions that this study aims to answer are:
Researchers will apply resin infiltration therapy to incisors affected by MIH and evaluate the results over a 12-month follow-up period. Participants will:
The results of this study are expected to contribute to the development of minimally invasive treatment options for children with MIH.
Children aged 6-14 years with molar incisor hypomineralization (MIH) will be evaluated for the presence of opaque lesions in their permanent incisors. Children with opaque lesions will be divided into two groups based on the classification published by Ghanim et al. in 2015: those with opaque areas limited to creamy-white to yellow-brown color. Teeth showing other developmental enamel defects (fluorosis, enamel hypoplasia, amelogenesis imperfecta, dental caries, etc.) will be excluded. The teeth in each of the two groups will be further subdivided into three subgroups, and treatments will be performed using Icon® (DMG, Hamburg, Germany) for resin infiltration, Opalustre (Ultradent Products, Cologne, Germany) for microabrasion, and Coxo CA-1 (Foshan Coxo Medical Instrument Co., Ltd., China) for air abrasion, either individually or in combination. The groups and procedures to be applied are planned as follows:
Group 1: Creamy-White opaque area, Icon Group 2: Creamy-White opaque area, Opalustre + Icon Group 3: Creamy-White opaque area, Coxo CA-1 + Icon Group 4: Yellow-Brown opaque area, Icon Group 5: Yellow-Brown opaque area, Opalustre + Icon Group 6: Yellow-Brown opaque area, Coxo CA-1 + Icon Informed consent forms will be signed by patients and their parents who wish to participate in the study.
The color stability and sensitivity of the opaque lesions after treatment will be checked at 1, 3, 6, 9, and 12 months. Standard photographs will be taken with a DSLR camera before treatment and at all control appointments.
A spectrophotometer will be used to evaluate color stability. The Schiff Cold Air Sensitivity Test (SCASS) and Visual Analog Scale (VAS) will be used to assess sensitivity. The validated COHIP-SF-19 questionnaire will be administered to children before treatment and 3-6 months after treatment to assess their quality of life. Parents will also be administered the P-CPQ questionnaire to assess their child's oral health and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Creamy/white colored lesions - Resin Infıltration | Experimental |
| |
| Creamy/white colored lesions - Microabrasion+Resin Infıltration | Experimental |
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| Creamy/white colored lesions - Air abrasion+Resin Infıltration | Experimental |
| |
| Yellow/brown colored lesions - Resin Infiltration | Experimental |
| |
| Yellow/brown colored lesions - Microabrasion+Resin Infiltration | Experimental |
| |
| Yellow/brown colored lesions - Air abrasion+Resin Infiltration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin Infiltration | Procedure | A minimally invasive treatment in which a low-viscosity resin material is applied to porous enamel lesions to reduce opacity, improve clinical appearance, and stabilize the enamel surface. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lesion Color and Clinical Appearance | Color change of hypomineralized enamel lesions will be objectively evaluated using a dental spectrophotometer. Color differences between baseline and follow-up measurements will be recorded to assess treatment effectiveness. | Baseline, 1 month, 3 months, 6 months, 9 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tooth Sensitivity (Visual Analog Scale) | Tooth sensitivity will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain). A standardized air stimulus will be applied to the tooth by the dentist, and the participant will rate the perceived sensitivity using the VAS scale. Higher scores indicate greater tooth sensitivity. Changes in sensitivity scores will be evaluated by comparing baseline and follow-up measurements. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zekiye Şeyma Gümüşboğa, Assistant Professor | Inonu University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İnönü University Faculty of Dentistry | Malatya | Battalgazi | 44320 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39067648 | Background | Hoan NQ, Huyen NP, Son DC, Thien DH, Sabet CJ, Ngoc VTN. Effectiveness of resin infiltration in the management of anterior teeth affected by molar incisor hypomineralisation (MIH): A systematic review and meta-analysis. J Dent. 2024 Oct;149:105254. doi: 10.1016/j.jdent.2024.105254. Epub 2024 Jul 26. | |
| 36861552 | Background |
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| Microabrasion Followed by Resin Infiltration | Procedure | A combined treatment protocol involving enamel microabrasion prior to resin infiltration to evaluate its effect on treatment efficacy, lesion appearance, and clinical outcomes in hypomineralized enamel lesions. |
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| Air Abrasion Followed by Resin Infiltration | Procedure | A combined minimally invasive treatment in which air abrasion is used for enamel surface preparation prior to resin infiltration to optimize resin penetration and improve esthetic and clinical outcomes in hypomineralized lesions. |
|
| Baseline, 1 month, 3 months, 6 months, 9 months and 12 months |
| Change in Tooth Sensitivity (Schiff Cold Air Sensitivity Scale) | Tooth sensitivity will be assessed by a trained dentist using the Schiff Cold Air Sensitivity Scale (SCASS) following standardized air stimulus application. The scale ranges from 0 to 3, where higher scores indicate greater tooth sensitivity. Changes in sensitivity scores will be evaluated by comparing baseline and follow-up measurements. | Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months |
| Change in Oral Health-Related Quality of Life (COHIP-SF-19) | Children will complete the Child Oral Health Impact Profile Short Form (COHIP-SF-19) questionnaire to assess oral health-related quality of life. Total scores range from 0 to 76, with higher scores indicating better oral health-related quality of life. Changes in quality-of-life scores will be evaluated by comparing baseline and follow-up assessments. | Baseline, 3 months and 6 months |
| Change in Oral Health-Related Quality of Life (Parental-Caregiver Perceptions Questionnaire) | Parents will complete the Parental-Caregiver Perceptions Questionnaire (P-CPQ) to evaluate their child's oral health-related quality of life. The total score ranges from 0 to 124, with higher scores indicating poorer oral health-related quality of life. Changes in quality-of-life scores will be evaluated by comparing baseline and follow-up assessments. | Baseline, 3 months, and 6 months |
| Jawdekar AM, Kamath S, Kale S, Mistry L. Assessment of oral health-related quality of life (OHRQoL) in children with molar incisor hypomineralization (MIH) - A systematic review and meta-analysis of observational studies. J Indian Soc Pedod Prev Dent. 2022 Oct-Dec;40(4):368-376. doi: 10.4103/jisppd.jisppd_27_23. |
| 38744567 | Background | Amend S, Stork S, Lucker S, Seipp A, Gartner U, Frankenberger R, Kramer N. Influence of different pre-treatments on the resin infiltration depth into enamel of teeth affected by molar-incisor hypomineralization (MIH). Dent Mater. 2024 Jul;40(7):1015-1024. doi: 10.1016/j.dental.2024.05.010. Epub 2024 May 13. |
| 32437856 | Background | Hasmun N, Vettore MV, Lawson JA, Elcock C, Zaitoun H, Rodd HD. Determinants of children's oral health-related quality of life following aesthetic treatment of enamel opacities. J Dent. 2020 Jul;98:103372. doi: 10.1016/j.jdent.2020.103372. Epub 2020 May 11. |
| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| 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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