title: Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 8. Assessing naso-labial appearance in 5-year-olds - a preliminary study.
abstract: OBJECTIVE
  Facial appearance is one of the most relevant measures of success in cleft lip and palate treatment. The aim was to assess nasolabial appearance at 5 years of age in all children in the project. In this part of the project the local protocol for lip closure continued to be used because the primary lip and nose operations were not part of the randomisation. The great majority of the surgeons used Millard's technique together with McComb's technique for the nose. One center used Tennison-Randalls technique and in one center the centers own technique as well as nose plugs were used.
  
  
  METHODS
  Three hundred and fifty-nine children participated in this part of the project. Standardised photos according to a specific protocol developed for the Scandcleft project were taken. Only the nasolabial area was shown, the surrounding facial features were masked. Three components were scored using a 5-point ordinal scale. A new developed Scandcleft Yardstick was used.
  
  
  RESULTS
  The reliability of the method was tested using the weighted kappa statistics. Both the interrater and intrarater reliability scores were good to very good. There were statistically significant differences between the three trials.
  
  
  CONCLUSIONS
  The Millard procedure combined with McComb technique had been used in the majority of the cases in all three trials. There were statistically significant differences between the three trials concerning upper lip, nasal form, and cleft side profile.
  
  
  BACKGROUND
  ISRCTN29932826.
authors.affiliation: a Copenhagen Cleft Palate Center, University Hospital of Copenhagen , Copenhagen , Denmark.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Mølsted
authors.affiliation: b Cleft Palate and Craniofacial Center, Helsinki University Central Hospital , Helsinki , Finland.
authors.forename: Kirsti
authors.initials: K
authors.lastname: Humerinta
authors.affiliation: c Cleft Palate Center , Aarhus , Denmark.
authors.forename: Annelise
authors.initials: A
authors.lastname: Küseler
authors.affiliation: d Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.
authors.forename: Pål
authors.initials: P
authors.lastname: Skaare
authors.affiliation: e Greater Manchester Cleft Lip and Palate Unit, Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Haydn
authors.initials: H
authors.lastname: Bellardie
authors.affiliation: f Dental School, University of Manchester , Manchester , UK.
authors.forename: William
authors.initials: W
authors.lastname: Shaw
authors.affiliation: g Stockholm Craniofacial Team, Division of Orthodontics, Department of Dental Medicine , Karolinska Institutet , Stockholm , Sweden.
authors.forename: Agneta
authors.initials: A
authors.lastname: Karsten
authors.affiliation: h Oral Health Center of Expertise/Western Norway , Bergen , Norway.
authors.forename: Paul
authors.initials: P
authors.lastname: Kåre Sæle
authors.affiliation: i Department of Odontology , Sahlgrenska Academy, University of Gothenburg , Gothenburg , Sweden.
authors.forename: Sara
authors.initials: S
authors.lastname: Rizell
authors.affiliation: j Department of Dentofacial Orthopedics, Maxillofacial Unit , University Hospital , Linköping , Sweden.
authors.forename: Agneta
authors.initials: A
authors.lastname: Marcusson
authors.affiliation: e Greater Manchester Cleft Lip and Palate Unit, Royal Manchester Childrens' Hospital , Manchester , UK.
authors.forename: Philip
authors.initials: P
authors.lastname: Eyres
authors.affiliation: d Department of Plastic and Reconstructive Surgery , Oslo University Hospital Rikshospitalet , Oslo , Norway.|k Dental School, University of Manchester , Manchester , UK.|l Statped Sørøst , Oslo , Norway.
authors.forename: Gunvor
authors.initials: G
authors.lastname: Semb
mesh_terms: D002648:Child; D002675:Child, Preschool; D002971:Cleft Lip / Q000175:diagnosis / Q000601:surgery*; D002972:Cleft Palate / Q000175:diagnosis / Q000601:surgery*; D004954:Esthetics; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D038622:Internationality; D016014:Linear Models; D008297:Male; D060052:Nasolabial Fold / Q000503:physiopathology*; D015588:Observer Variation; D011183:Postoperative Complications / Q000453:epidemiology / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D019651:Plastic Surgery Procedures / Q000009:adverse effects / Q000379:methods*; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome
keywords: 5 years; RCT studies; Scandcleft; facial esthetics; multicenter study; nasolabial appearance; unilateral cleft lip and palate