ISRCTN70438627.
Trial name or title | Early restorative crown therapy in children and adolescents with amelogenesis imperfecta (AI): a prospective double‐blind randomised controlled trial |
Methods | Single centre double‐blind randomised controlled trial, split‐mouth design |
Participants | Setting: Centre for Oral Rehabilitation, special care department for children and adolescents, Falun, Dalarna, Sweden Inclusion criteria: Children and adolescents with AI, 6 to 25 years of age, referred for oral rehabilitation Exclusion criteria: AI in combination with syndromes including mental retardation Randomised: 28 (15 boys and 13 girls). 12 to 23 years of age, all of Caucasian origin AI type was recorded as either hypoplastic type (14) or hypomineralised or hypomaturation type (14) |
Interventions | Treatment with Procera crown therapy with Zirconia inner coping cemented with Rely X ARC cement or E‐MAX crowns with Zirconia inner coping cemented with Rely X ARC cement Follow‐up examinations: 1 month, 1 year and 2 years |
Outcomes | Primary outcomes
Secondary outcomes
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Starting date | 1 January 2009 |
Contact information | Professor Goran Dahllöf Karolinska Institutet Department of Dental Medicine Division of Orthodontics and Pediatric Dentistry POB 4064 Huddinge SE‐14104 Sweden |
Funding | Centre for Clinical Research, Public Dental Service Dalarna (Sweden) |
Notes | 1‐year results were published as an abstract in 2012 |