title: Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds.
abstract: OBJECTIVE
  Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP.
  
  
  METHODS
  Three parallel randomised clinical trials were undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK.
  
  
  METHODS
  Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Study models of 418 patients (273 boys) at the mean age of 5.1 years (range = 4.8-7.0) were available. Dental arch relationships were assessed using the 5-year index by a blinded panel of 16 orthodontists. Kappa statistics were calculated to assess reliability. The trials were tested statistically with t- and Chi-square tests.
  
  
  RESULTS
  Good-to-very good levels of intra- and interrater reliability were obtained (0.71-0.94 and 0.70-0.87). Comparisons within each trial showed no statistically significant differences in the mean 5-year index scores or their distributions between the common method and the local team protocol. The mean index scores varied from 2.52 (Trial 2, Arm C) to 2.94 (Trial 3, Arm D).
  
  
  CONCLUSIONS
  The results of the three trials do not provide statistical evidence that one technique is better than the others. Further analysis of the possible influence of individual surgical skill and learning curve are being pursued in this dataset.
  
  
  BACKGROUND
  ISRCTN29932826.
authors: a Department of Plastic Surgery, Cleft Palate and Craniofacial Center , Helsinki University Hospital , Helsinki , Finland.
authors: Arja
authors: A
authors: Heliövaara
authors: b Cleft Palate Center , Aarhus , Denmark.
authors: Annelise
authors: A
authors: Küseler
authors: c Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet , Oslo , Norway.
authors: Pål
authors: P
authors: Skaare
authors: d Dental School, University of Manchester , Manchester , UK.
authors: William
authors: W
authors: Shaw
authors: e Copenhagen Cleft Palate Center , University Hospital of Copenhagen , Denmark.
authors: Kirsten
authors: K
authors: Mølsted
authors: f Division of Orthodontics, Department of Dental Medicine, Stockholm Craniofacial Team , Karolinska Institutet , Stockholm , Sweden.
authors: Agneta
authors: A
authors: Karsten
authors: c Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet , Oslo , Norway.
authors: Eli
authors: E
authors: Brinck
authors: g Orthodontic clinic , University Clinics of Odontology Gothenburg , Sweden.
authors: Sara
authors: S
authors: Rizell
authors: h Dentofacial Orthopedics, Maxillofacial Unit , University Hospital , Linköping , Sweden.
authors: Agneta
authors: A
authors: Marcusson
authors: i Oral Health Center of Excellence/Western Norway , Bergen , Norway.
authors: Paul
authors: P
authors: Sæle
authors: a Department of Plastic Surgery, Cleft Palate and Craniofacial Center , Helsinki University Hospital , Helsinki , Finland.
authors: Kirsti
authors: K
authors: Hurmerinta
authors: c Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet , Oslo , Norway.
authors: Elisabeth
authors: E
authors: Rønning
authors: g Orthodontic clinic , University Clinics of Odontology Gothenburg , Sweden.
authors: Midia
authors: M
authors: Najar Chalien
authors: j Greater Manchester Cleft Unit, Royal Manchester Children's Hospital , Manchester , UK.
authors: Haydn
authors: H
authors: Bellardie
authors: j Greater Manchester Cleft Unit, Royal Manchester Children's Hospital , Manchester , UK.
authors: Jeanette
authors: J
authors: Mooney
authors: d Dental School, University of Manchester , Manchester , UK.
authors: Phil
authors: P
authors: Eyres
authors: k Dental School, University of Manchester , Manchester , UK.|l Department of Plastic and Reconstructive Surgery, Oslo University Hospital, Rikshospitalet and Statped Sørøst , Oslo , Norway.
authors: Gunvor
authors: G
authors: Semb
mesh_terms: D002675:Child, Preschool; D002971:Cleft Lip / Q000175:diagnosis / Q000601:surgery*; D002972:Cleft Palate / Q000175:diagnosis / Q000601:surgery*; D003724:Dental Arch / Q000002:abnormalities* / Q000503:physiopathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D038622:Internationality; D008297:Male; D011183:Postoperative Complications / Q000175:diagnosis / Q000628:therapy; D016032:Randomized Controlled Trials as Topic; D019651:Plastic Surgery Procedures / Q000009:adverse effects / Q000379:methods*; D020127:Recovery of Function; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome
keywords: Randomised control trials; Scandcleft; dental arch relationship; dental model (cast); intercentre study; the 5-year index; unilateral cleft lip and palate