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Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: maxillary growth at eight years of age

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DOI

  1. Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: dental anomalies in 8-year olds

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate. Dental arch relationships in 8 year-olds

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Association between third mandibular molar impaction and degree of root development in adolescents

    Research output: Contribution to journalJournal articleResearchpeer-review

  • Annelise Küseler
  • Kirsten Mølsted
  • Agneta Marcusson
  • Arja Heliövaara
  • Agneta Karsten
  • Haydn Bellardie
  • Paul Sæle
  • Eli Brinck
  • Pål Skaare
  • Sara Rizell
  • Midia Najar Chalien
  • Jeanette Mooney
  • Philip Eyres
  • William Shaw
  • Gunvor Semb
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OBJECTIVES: To assess differences in craniofacial growth at 8 years of age according to the different protocols for primary cleft surgery in the Scandcleft project.

DESIGN AND SETTING: Prospective, randomized, controlled clinical trial (RCT) involving 10 centres, including non-syndromic Caucasians with unilateral cleft lip and palate (UCLP). In Trial 1, a common surgical method (1a) with soft palate closure at 3-4 months of age and hard palate closure at 12 months of age was tested against similar surgery but with hard palate repair at 36 months (delayed hard palate closure) (1b). In Trial 2, the common method (2a) was tested against simultaneous closure of both hard and soft palate at 1 year (2c). In Trial 3, the common method (3a) was tested against hard palate closure together with lip closure at 3 months of age and soft palate closure at 1 year of age (3d). Participants were randomly allocated by use of a dice. Operator blinding was not possible but all raters of all outcomes were blinded.

SUBJECTS AND METHODS: The total number of participating patients at 8 years of age was 429. Lateral cephalograms (n = 408) were analysed. The cephalometric angles SNA and ANB were chosen for assessing maxillary growth for this part of the presentation.

RESULTS: Within each trial (Trial 1a/1b, Trial 2a/2c, and Trial 3a/3d), there was no difference in cephalometric values between the common and the local arm. There were no statistically significant differences in the SNA and ANB angles between the common arm in Trial 1a (mean SNA 77.8, mean ANB 2.6) and Trial 2a (mean SNA 79.8, mean ANB 3.6) and no difference between Trial 1a and Trial 3a, but a statistical difference could be seen between Trial 2a and Trial 3a (mean SNA 76.9, mean ANB 1.7). However, the confidence interval was rather large. Intra- and inter-rater reliability were within acceptable range.

CONCLUSIONS: The timing and the surgical method is not of major importance as far as growth outcomes (SNA and ANB) in UCLP are concerned.

REGISTRATION: ISRCTN29932826.

PROTOCOL: The protocol was not published before trial commencement.

Original languageEnglish
JournalAngle Orthodontist
Volume42
Issue number1
Pages (from-to)24-29
Number of pages6
ISSN0003-3219
DOIs
Publication statusPublished - Feb 2020

    Research areas

  • Child, Cleft Lip/surgery, Cleft Palate/surgery, Follow-Up Studies, Humans, Maxilla/growth & development, Maxillofacial Development, Prospective Studies, Randomized Controlled Trials as Topic, Reproducibility of Results, Time Factors, scandcleft
  • Health Sciences

ID: 61799981