Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: comparison of dental arch relationships and dental indices at 5, 8, and 10 years

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  • Arja Heliövaara, University of Helsinki, Finland
  • Annelise Küseler
  • Pål Skaare, University of Oslo, Norge
  • Haydn Bellardie, University of Manchester, University of Cape Town, Storbritannien
  • Kirsten Mølsted, Københavns Universitet, Danmark
  • Agneta Karsten, Section for Orthodontics, Division of Orthodontics and Pedodontics, Department of Dental Medicine, Karolinska Institutet and Stockholm Craniofacial Team, Sweden, Sverige
  • Agneta Marcusson, Maxillofacial Unit, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sverige
  • Sara Rizell, Specialist Clinic for Orthodontics, University Clinics of Odontology, Public Dental Health Service, Västra Götaland Region, Sweden, Sverige
  • Eli Brinck, University of Oslo, Norge
  • Paul Sæle, Oral Health Center of Expertise, Western Norway, Hordaland County, Bergen
  • ,
  • Midia Najar Chalien, Specialist Clinic for Orthodontics, University Clinics of Odontology, Public Dental Health Service, Västra Götaland Region, Sweden, Sverige
  • Jeanette Mooney, University of Manchester, Storbritannien
  • Phil Eyres, University of Manchester, Storbritannien
  • William Shaw, University of Manchester, Storbritannien
  • Gunvor Semb, University of Oslo, University of Manchester, Norge

BACKGROUND AND TRIAL DESIGN: The Scandcleft intercentre study evaluates the outcomes of four surgical protocols (common method Arm A, and methods B, C, and D) for treatment of children with unilateral cleft lip and palate (UCLP) in a set of three randomized trials of primary surgery (Trials 1, 2, and 3).

OBJECTIVES: To evaluate and compare dental arch relationships of 5-, 8-, and 10-year-old children with UCLP after four different protocols of primary surgery and to compare three dental indices. The results are secondary outcomes of the overall trial.

METHODS: Study models taken at the ages of 5 (n = 418), 8 (n = 411), and 10 years (n = 410) were analysed by a blinded panel of orthodontists using the Eurocran index, the 5-year-olds' (5YO) index, and the GOSLON Yardstick. Student's t-test, Pearson's correlation, chi-square test, and kappa statistics were used in statistical analyses.

RESULTS: The reliability of the dental indices varied between moderate and very good, and those of the Eurocran palatal index varied between fair and very good. Significant correlations existed between the dental indices at all ages. No differences were found in the mean 5-, 8-, and 10-year index scores or their distributions within surgical trials. Comparisons between trials detected significantly better mean index scores in Trial 2 Arm C (at all ages) and in Trial 1 Arm B (at 5 and 10 years of age) than in Trial 3 Arm D. The mean Eurocran dental index scores of the total material at 5, 8, and 10 years of age were 2.50, 2.60, and 2.26, and those of the 5YO index and GOSLON Yardstick were 2.77, 2.90, and 2.54, respectively. At age 10 years, 75.8% of the patients had had orthodontic treatment.

CONCLUSIONS: The results of these three trials do not provide evidence that one surgical method is superior to the others. The reliabilities of the dental indices were acceptable, and significant correlations existed between the indices at all ages. The reliability of the Eurocran palatal index was questionable.

TRIAL REGISTRATION: ISRCTN29932826.

OriginalsprogEngelsk
Artikelnummer055
TidsskriftEuropean Journal of Orthodontics
Vol/bind44
Nummer3
Sider (fra-til)258-267
Antal sider10
ISSN0141-5387
DOI
StatusUdgivet - jun. 2022

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