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Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate. Dental arch relationships in 8 year-olds.
Eur J Orthod. 2020 Jan 27; 42(1):1-7.EJ

Abstract

BACKGROUND AND TRIAL DESIGN

The Scandcleft intercentre study evaluates the outcomes of four surgical protocols for treatment of children with unilateral cleft lip and palate (UCLP). Originally 10 cleft centres in Denmark, Finland, Norway, Sweden, and the UK participated in a set of three randomized trials of primary surgery. Three groups of centres (Trials 1, 2, and 3) tested their traditional local surgical protocols (Arms B, C, and D) against a common protocol (Arm A).

OBJECTIVES

To evaluate dental arch relationships at age 8 years after four different protocols of primary surgery for UCLP. These results are secondary outcomes of the overall trial.

METHODS

Study models of 411 children (270 boys, 141 girls) with non-syndromic UCLP at a mean age of 8.1 (range 7.0-10.0) years were available. Dental arch relationships were analysed using the GOSLON Yardstick by a blinded panel of 11 orthodontists. To assess reliability, Kappa statistics were calculated. The trials were tested statistically with t-tests.

RESULTS

Comparisons within each trial showed no statistically significant differences in the mean 8-year index scores or their distributions between the common protocol and the local team protocol. The mean index scores were Trial 1: Arm A 3.03, Arm B 2.82, Trial 2: Arm A 2.78, Arm C 2.64, and Trial 3: Arm A 3.06, Arm D 3.08. Comparisons between the trials detected a significantly (P < 0.005) better mean index score Trial 2 Arm C than in Trial 3 Arm D. The intra- and inter-rater reliabilities were acceptable.

CONCLUSION

The results of these three trials do not provide evidence that one surgical protocol is better than the others.

TRIAL REGISTRATION

ISRCTN29932826.

Authors+Show Affiliations

Cleft Palate and Craniofacial Center, Department of Plastic Surgery, Helsinki University Hospital, Finland.Department of Plastic and Reconstructive Surgery, Oslo University Hospital Rikshospitalet, Norway.Cleft Palate Center and University Hospital Aarhus and University of Aarhus, Denmark.Dental School, University of Manchester, UK.Copenhagen Cleft Palate Center, University Hospital of Copenhagen, Denmark.Section for Orthodontics, Division of Orthodontics and Pedodontics, Department of Dental Medicine, Karolinska Institutet and Stockholm Craniofacial Team, Sweden.Maxillofacial Unit and Department of Clinical and Experimental Medicine, Linköping University, Sweden.Department of Plastic and Reconstructive Surgery, Oslo University Hospital Rikshospitalet, Norway.Specialist Clinic for Orthodontics, University Clinics of Odontology, Public Dental Health Service, Västra Götaland Region, Sweden.Oral Health Center of Expertise/Western Norway, Bergen, Norway.Specialist Clinic for Orthodontics, University Clinics of Odontology, Public Dental Health Service, Västra Götaland Region, Sweden.Dental School, University of Manchester, UK. The University of the Western Cape, South Africa.Dental School, University of Manchester, UK.Dental School, University of Manchester, UK.Department of Plastic and Reconstructive Surgery, Oslo University Hospital Rikshospitalet, Norway. Dental School, University of Manchester, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31579909

Citation

Heliövaara, Arja, et al. "Scandcleft Randomized Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Dental Arch Relationships in 8 Year-olds." European Journal of Orthodontics, vol. 42, no. 1, 2020, pp. 1-7.
Heliövaara A, Skaare P, Küseler A, et al. Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate. Dental arch relationships in 8 year-olds. Eur J Orthod. 2020;42(1):1-7.
Heliövaara, A., Skaare, P., Küseler, A., Shaw, W., Mølsted, K., Karsten, A., Marcusson, A., Brinck, E., Rizell, S., Sæle, P., Najar Chalien, M., Bellardie, H., Mooney, J., Eyres, P., & Semb, G. (2020). Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate. Dental arch relationships in 8 year-olds. European Journal of Orthodontics, 42(1), 1-7. https://doi.org/10.1093/ejo/cjz067
Heliövaara A, et al. Scandcleft Randomized Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Dental Arch Relationships in 8 Year-olds. Eur J Orthod. 2020 Jan 27;42(1):1-7. PubMed PMID: 31579909.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate. Dental arch relationships in 8 year-olds. AU - Heliövaara,Arja, AU - Skaare,Pål, AU - Küseler,Annelise, AU - Shaw,William, AU - Mølsted,Kirsten, AU - Karsten,Agneta, AU - Marcusson,Agneta, AU - Brinck,Eli, AU - Rizell,Sara, AU - Sæle,Paul, AU - Najar Chalien,Midia, AU - Bellardie,Haydn, AU - Mooney,Jeanette, AU - Eyres,Phil, AU - Semb,Gunvor, PY - 2019/10/4/pubmed PY - 2020/3/4/medline PY - 2019/10/4/entrez SP - 1 EP - 7 JF - European journal of orthodontics JO - Eur J Orthod VL - 42 IS - 1 N2 - BACKGROUND AND TRIAL DESIGN: The Scandcleft intercentre study evaluates the outcomes of four surgical protocols for treatment of children with unilateral cleft lip and palate (UCLP). Originally 10 cleft centres in Denmark, Finland, Norway, Sweden, and the UK participated in a set of three randomized trials of primary surgery. Three groups of centres (Trials 1, 2, and 3) tested their traditional local surgical protocols (Arms B, C, and D) against a common protocol (Arm A). OBJECTIVES: To evaluate dental arch relationships at age 8 years after four different protocols of primary surgery for UCLP. These results are secondary outcomes of the overall trial. METHODS: Study models of 411 children (270 boys, 141 girls) with non-syndromic UCLP at a mean age of 8.1 (range 7.0-10.0) years were available. Dental arch relationships were analysed using the GOSLON Yardstick by a blinded panel of 11 orthodontists. To assess reliability, Kappa statistics were calculated. The trials were tested statistically with t-tests. RESULTS: Comparisons within each trial showed no statistically significant differences in the mean 8-year index scores or their distributions between the common protocol and the local team protocol. The mean index scores were Trial 1: Arm A 3.03, Arm B 2.82, Trial 2: Arm A 2.78, Arm C 2.64, and Trial 3: Arm A 3.06, Arm D 3.08. Comparisons between the trials detected a significantly (P < 0.005) better mean index score Trial 2 Arm C than in Trial 3 Arm D. The intra- and inter-rater reliabilities were acceptable. CONCLUSION: The results of these three trials do not provide evidence that one surgical protocol is better than the others. TRIAL REGISTRATION: ISRCTN29932826. SN - 1460-2210 UR - https://www.unboundmedicine.com/medline/citation/31579909/Scandcleft_randomized_trials_of_primary_surgery_for_unilateral_cleft_lip_and_palate__Dental_arch_relationships_in_8_year_olds_ L2 - https://academic.oup.com/ejo/article-lookup/doi/10.1093/ejo/cjz067 DB - PRIME DP - Unbound Medicine ER -