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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients treated with preformed metal crowns | Experimental | All patients included received a preformed metal crown on their HSPM affected teeth. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placing preformed metal crowns using Hall technique. | Other | 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). |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Declerck, Prof. Dr. | Contact | +3216332307 | dominique.declerck@uzleuven.be | |
| Emily Mampay | Contact | emily.mampay@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Dominique Declerck, Prof. Dr. | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30648259 | Background | Mayhew D, Mendonca V, Murthy BVS. A review of ASA physical status - historical perspectives and modern developments. Anaesthesia. 2019 Mar;74(3):373-379. doi: 10.1111/anae.14569. Epub 2019 Jan 15. | |
| 25916282 | Background | Ghanim A, Elfrink M, Weerheijm K, Marino R, Manton D. A practical method for use in epidemiological studies on enamel hypomineralisation. Eur Arch Paediatr Dent. 2015 Jun;16(3):235-46. doi: 10.1007/s40368-015-0178-8. Epub 2015 Apr 28. |
| Label | URL |
|---|---|
| Restorative management of dental enamel defects in the primary dentition | View source |
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| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| ID | Term |
|---|---|
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
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|
| 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 |
| 17518963 | Background | Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x. |
| 27433051 | Background | Kulkarni P, Agrawal S, Bansal A, Jain A, Tiwari U, Anand A. Assessment of nickel release from various dental appliances used routinely in pediatric dentistry. Indian J Dent. 2016 Apr-Jun;7(2):81-5. doi: 10.4103/0975-962X.184649. |
| 26196586 | Result | Tonmukayakul U, Martin R, Clark R, Brownbill J, Manton D, Hall M, Armfield J, Smith M, Shankumar R, Sivasithamparam K, Martin-Kerry J, Calache H. Protocol for the Hall Technique study: A trial to measure clinical effectiveness and cost-effectiveness of stainless steel crowns for dental caries restoration in primary molars in young children. Contemp Clin Trials. 2015 Sep;44:36-41. doi: 10.1016/j.cct.2015.07.005. Epub 2015 Jul 18. |
| 28904324 | Result | Wada K, Kanazawa H, Kudo M, Kindaichi J, Miyashin M. Management of developmental enamel defects in the primary dentition. J Oral Sci. 2017;59(3):457-460. doi: 10.2334/josnusd.16-0805. |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |