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. 2013 Jun 6;2013(6):CD007157. doi: 10.1002/14651858.CD007157.pub2

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
  • Quality of restorations after 1 month, 1 year and a 2‐year observation period according to Ryge & De Vinzenci (1983)

  • Sensitivity, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline, 1 month and 2 years


Secondary outcomes
  • Dental caries according to Amarante et al (1998)

  • Gingivitis and periodontitis according to Nyman and Linde (2003)

  • Apical status according to Örstavik (1986)

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