Arja Heliövaara1, Annelise Küseler2, Pål Skaare3, William Shaw4, Kirsten Mølsted5, Agneta Karsten6, Eli Brinck3, Sara Rizell7, Agneta Marcusson8, Paul Sæle9, Kirsti Hurmerinta1, Elisabeth Rønning3, Midia Najar Chalien7, Haydn Bellardie10, Jeanette Mooney10, Phil Eyres4, Gunvor Semb11,12. 1. a Department of Plastic Surgery, Cleft Palate and Craniofacial Center , Helsinki University Hospital , Helsinki , Finland. 2. b Cleft Palate Center , Aarhus , Denmark. 3. c Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet , Oslo , Norway. 4. d Dental School, University of Manchester , Manchester , UK. 5. e Copenhagen Cleft Palate Center , University Hospital of Copenhagen , Denmark. 6. f Division of Orthodontics, Department of Dental Medicine, Stockholm Craniofacial Team , Karolinska Institutet , Stockholm , Sweden. 7. g Orthodontic clinic , University Clinics of Odontology Gothenburg , Sweden. 8. h Dentofacial Orthopedics, Maxillofacial Unit , University Hospital , Linköping , Sweden. 9. i Oral Health Center of Excellence/Western Norway , Bergen , Norway. 10. j Greater Manchester Cleft Unit, Royal Manchester Children's Hospital , Manchester , UK. 11. k Dental School, University of Manchester , Manchester , UK. 12. l Department of Plastic and Reconstructive Surgery, Oslo University Hospital, Rikshospitalet and Statped Sørøst , Oslo , Norway.
Abstract
BACKGROUND AND AIM: 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. DESIGN: 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). CONCLUSION: 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. TRIAL REGISTRATION: ISRCTN29932826.
BACKGROUND AND AIM: 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. DESIGN: 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). CONCLUSION: 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. TRIAL REGISTRATION: ISRCTN29932826.
Entities:
Keywords:
Randomised control trials; Scandcleft; dental arch relationship; dental model (cast); intercentre study; the 5-year index; unilateral cleft lip and palate
Authors: Anne F Klassen; Karen Wy Wong Riff; Natasha M Longmire; Asteria Albert; Gregory C Allen; Mustafa Asim Aydin; Stephen B Baker; Stefan J Cano; Andrew J Chan; Douglas J Courtemanche; Marieke M Dreise; Jesse A Goldstein; Timothy E E Goodacre; Karen E Harman; Montserrat Munill; Aisling O Mahony; Mirta Palomares Aguilera; Petra Peterson; Andrea L Pusic; Rona Slator; Mia Stiernman; Elena Tsangaris; Sunil S Tholpady; Federico Vargas; Christopher R Forrest Journal: CMAJ Date: 2018-04-16 Impact factor: 8.262
Authors: Elena Tsangaris; Karen W Y Wong Riff; Federico Vargas; Mirta Palomares Aguilera; Macarena Miranda Alarcón; Asteria Albert Cazalla; Lehana Thabane; Achilleas Thoma; Anne F Klassen Journal: Health Qual Life Outcomes Date: 2017-11-28 Impact factor: 3.186
Authors: Elena Tsangaris; Karen W Y Wong Riff; Tim Goodacre; Christopher R Forrest; Marieke Dreise; Jonathan Sykes; Tristan de Chalain; Karen Harman; Aisling O'Mahony; Andrea L Pusic; Lehana Thabane; Achilleas Thoma; Anne F Klassen Journal: Plast Reconstr Surg Glob Open Date: 2017-04-25
Authors: Karen W Y Wong Riff; Elena Tsangaris; Tim Goodacre; Christopher R Forrest; Andrea L Pusic; Stefan J Cano; Anne F Klassen Journal: BMJ Open Date: 2017-01-11 Impact factor: 2.692
Authors: A K Wills; O Mahmoud; A Hall; D Sell; J Smallridge; L Southby; S Toms; A Waylen; Y Wren; A R Ness; J R Sandy Journal: Orthod Craniofac Res Date: 2017-06 Impact factor: 1.826
Authors: Christine B Staudt; Julia Bollhalder; Martina Eichenberger; Giorgio La Scala; Georges Herzog; Daniel B Wiedemeier; Gregory S Antonarakis Journal: Cleft Palate Craniofac J Date: 2021-07-08