Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects

Study Overview
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Brief Summary
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In this prospective randomized clinical trial, the is aim to compare the clinical and radiographic success of 3 minimally invasive treatment protocols on permanent first molars affected with MIH over 24 months. A total of 135 children/molar teeth (N=45 per group) between the ages of 6-16 years with MIH will be recruited at the post-graduate clinics at Jordan University of Science and Technology (JUST).

Detailed Description
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Background: The term molar-incisor hypomineralization (MIH) is defined as 'hypomineralization of systemic origin, presenting as demarcated, qualitative defects of enamel of one to four first permanent molars (FPMs) frequently associated with affected incisors. There are no clinical studies on use of minimally invasive techniques as restorative treatments for molars affected by MIH. Aim: The aim of this clinical trial is to compare the clinical and radiographic success of 3 minimally invasive treatment protocols on permanent first molars affected with MIH over 24 months. Methods: A total of 135 children/molar teeth (N=45 per group) between the ages of 6-16 years with MIH will be recruited for this prospective randomized clinical trial in the post-graduate clinics at JUST. Clinical and radiographic examination will be done. Participants will be randomly allocated to one of the three treatment modalities: For groups 1 and 2, silver diamine fluoride (SDF) will be clinically applied using cotton roll isolation on the first visit for three minutes after cleaning the tooth with gauze. After 1 week, the carious lesion will be examined for signs of caries arrest using two criteria: the color turning darker black and increased hardness of the lesion rather than soft texture (assessed using an excavator), if the criteria are met, the tooth will be restored with high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC) for group 1, or only with a SCC for group 2. If not met, the carious lesion will be assumed to be still active, and a reapplication of SDF will be done before restoring the tooth with HVGIC and SCC. In group 3, the tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with HVGIC and a SCC. Follow up will be done for all groups at 3 months, 6 months, 12 months, and 24 months to record specified clinical and radiographic criteria as outcome measures of success. Expected results: It is expected that there will be no difference between different minimally invasive restorative treatments for MIH; namely, restoring teeth using a SSC after SMART (SDF and HVGIC), SDF treatment alone, or ART (HVGIC alone).

Official Title
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Outcome of Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects: a Randomized Clinical Trial

Conditions
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Molar Incisor Hypomineralization

Intervention / Treatment
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* Procedure: SDF
* Procedure: HVGIC restoration
* Procedure: SSC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Permanent molars with MIH with the following MIH indices (2a, 2b, 3, 4a, 4b) affected by caries (ICDAS 3 or 4) or post eruptive breakdown. Restorable teeth Permanent molars with MIH with NO clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis. Clear band of dentine radiographically between the carious lesion and the pulp. Exclusion Criteria: Medically compromised patients. Permanent molars with MIH with the following indices (1, 2c, 4c, 0, 1). Permanent molars with MIH with severe post eruptive breakdown therefore, unrestorable. Permanent molars with MIH with clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis. No clear band of dentine radiographically between the carious lesion and the pulp.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: SDF, HVGIC & SSC<br>Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC). | Procedure: SDF<br>* Silver diamine fluoride<br>Procedure: HVGIC restoration<br>* High viscosity glass ionomer restoration<br>Procedure: SSC<br>* Stainless steel crown<br>|
| Active Comparator: Group 2: SDF & SSC<br>Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a SSC only. | Procedure: SDF<br>* Silver diamine fluoride<br>Procedure: SSC<br>* Stainless steel crown<br>|
| Active Comparator: Group 3: HVGIC & SSC<br>The tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC). | Procedure: HVGIC restoration<br>* High viscosity glass ionomer restoration<br>Procedure: SSC<br>* Stainless steel crown<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful restoration | SSC is clinically intact (not perforated), retentive (not lost), in proper occlusion, with no gingival inflammation | After 1 year | 
| Functional tooth clinically | Tooth should have no symptoms of pain, mobility or tenderness to percussion | After 1 year | 
| Healthy periapical region radiographically | No signs of periapical pathology on radiograph | After 1 year |