PMCs as a Treatment of Children With HSPM Using the HT

Study Overview
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Brief Summary
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Hypomineralised primary second molars are primary molars with a developmental disorder of the enamel. Preformed metal crowns already have good results for the treatment of caries on primary molars. In this study the aim is to investigate the clinical success and overall survival of preformed metal crowns as a treatment for hypomineralised primary molars. The crowns were placed using the Hall technique which is a simplified way of placing these crowns.

Official Title
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Preformed Metal Crowns (PMCs) as a Treatment of Children With Hypomineralised Second Primary Molars (HSPM) Using the Hall Technique (HT)

Conditions
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Hypomineralization of Enamel

Intervention / Treatment
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* Other: Placing preformed metal crowns using Hall technique.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 2-12 years American Society of Anesthesiologists(ASA)-score I: healthy patient hypomineralisation grade: 2-6 caries with an International Caries Detection and Assessment System (ICDAS)- score: 0-3 limited provoked pain complaint Exclusion Criteria: caries with an ICDAS-score: 4-6 pulpitis pain complaints infection (clinical and/or radiographic) >1/3 root resorption allergies to the used materials

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 144 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients treated with preformed metal crowns<br>All patients included received a preformed metal crown on their HSPM affected teeth. | Other: Placing preformed metal crowns using Hall technique.<br>* Preformed metal crowns (3M™ ESPE™ STAINLESS STEEL CROWNS) were placed after using separation elastics (Dentalastics® separators, DENTAURUM). The crowns were cemented using is a self-curing, radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement (Ketac™ Cem Plus Luting Cement, 3M™ ESPE™). The technique used to place the crowns was the Hall technique (technique without tooth preparation).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The clinical success of preformed metal crowns using Hall technique on hypomineralised second primary molars based on clinical acceptable results. | The results are clinical acceptable when there are no clinical signs of infection of the tooth, no caries development or heavy bleeding of the gingiva (after probing). | 1-2 year | 
| The overall survival rate of preformed metal crowns using Hall technique on hypomineralised second primary molars is defined as acceptable clinical outcomes. | The outcomes are clinically acceptable when there are no signs of infection (abscess) or caries. | 1-2 year | 
| The overall survival rate of preformed metal crowns using Hall technique on hypomineralised second primary molars is defined as acceptable radiographical outcomes. | The outcomes are radiographical acceptable when no signs of infection or interproximal bone loss are seen on the radiographs. | 1-2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The results can be affected by bruxism. Signs of bruxism will not mean failure. We will rate the wear as acceptable or successful. This bruxism will be measured by clinical signs of wear on the crowns. | When the wear of the crown is limited to minimal loss of metal, it is rated successful. When the wear is going through the full thickness of the crown until the underlying tooth structure, it is rated as acceptable. | 1-2 year | 
| The oral hygiene of the patient will be measured using the Simplified Oral Hygiene Index. The minimum value is 0: clean. The maximum value is 3: tooth surface covered with >2/3 soft dental plaque. The higher the score, the worse the outcome. | Oral hygiene of the patients scored as debris >1/3 of the crown surface is scored as bad oral hygiene. Bad oral hygiene implies a higher prevalence of (heavy) bleeding of the gingiva after probing. Which has a significant influence on the clinical success of the crowns. | 1-2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preformed metal crowns, Hall technique