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Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: occlusion in 8-year-olds according to the Modified Huddart and Bodenham index.
Eur J Orthod. 2020 Jan 27; 42(1):15-23.EJ

Abstract

BACKGROUND

The Scandcleft international multicenter study is a prospective clinical trial of the long-term outcome after four different surgical protocols for palatal closure in patients born with unilateral cleft lip and palate (UCLP). This paper is one of a series of follow-up studies in 8-year olds.

OBJECTIVES

To evaluate the dental occlusion of 8-year-old patients after four different protocols of primary surgery for UCLP.

TRIAL DESIGN

Ten cleft centres in five countries tested three different surgical procedures for primary palatal repair in three parallel trials (Arms B, C, and D) against a common procedure (Arm A).

METHODS

Initially 448 children born with non-syndromic UCLP were included in the project. At 8 years of age, 428 children remained in the study. Dental casts of 411 patients (270 boys, 141 girls), mean age 8.1 years (range 7.0-10.0) were taken. The casts were blindly assessed with the Modified Huddart and Bodenham (MHB) index by four orthodontists. The main outcome measures were anterior (+2 to -6) and posterior (0 to -8) mean scores. Comparisons were made with previous data in 5-year-olds.

RESULTS

The inter- and intra-examiner reliability was good to excellent (0.75-0.90; 0.73-0.97), respectively. The mean total scores varied from -7.09 (Trial 2C) to -10.13 (Trial 3D). The mean anterior scores varied from -1.75 (Trial 2C) to -3.18 (Trial 1A). The mean posterior cleft-side scores varied from -4.32 (Trial 1B) to -5.21 (Trial 3D) and the mean non-cleft-side scores varied from -0.88 (Trial 2C) to -2.40 (Trial 3A). No significant differences were found within the trials. A significant difference was found between Trials 2 and 3 (Arm C/D) for the total score (P = 0.004).

CONCLUSIONS

There was no evidence of clinically significant differences in occlusion between the two surgical methods in each trial or between the trials. All mean scores showed more negative values in 8-year-olds compared with previously reported values in 5-year-olds.

TRIAL REGISTRATION

ISRCTN29932826.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

31586176

Citation

Karsten, Agneta, et al. "Scandcleft Randomized Trials of Primary Surgery for Unilateral Cleft Lip and Palate: Occlusion in 8-year-olds According to the Modified Huddart and Bodenham Index." European Journal of Orthodontics, vol. 42, no. 1, 2020, pp. 15-23.
Karsten A, Marcusson A, Rizell S, et al. Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: occlusion in 8-year-olds according to the Modified Huddart and Bodenham index. Eur J Orthod. 2020;42(1):15-23.
Karsten, A., Marcusson, A., Rizell, S., Chalien, M. N., Heliövaara, A., Küseler, A., Skaare, P., Brinck, E., Shaw, W., Bellardie, H., Mooney, J., Mølsted, K., Sæle, P., Eyres, P., & Semb, G. (2020). Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: occlusion in 8-year-olds according to the Modified Huddart and Bodenham index. European Journal of Orthodontics, 42(1), 15-23. https://doi.org/10.1093/ejo/cjz077
Karsten A, et al. Scandcleft Randomized Trials of Primary Surgery for Unilateral Cleft Lip and Palate: Occlusion in 8-year-olds According to the Modified Huddart and Bodenham Index. Eur J Orthod. 2020 Jan 27;42(1):15-23. PubMed PMID: 31586176.
* 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: occlusion in 8-year-olds according to the Modified Huddart and Bodenham index. AU - Karsten,Agneta, AU - Marcusson,Agneta, AU - Rizell,Sara, AU - Chalien,Midia Najar, AU - Heliövaara,Arja, AU - Küseler,Annelise, AU - Skaare,Pål, AU - Brinck,Eli, AU - Shaw,William, AU - Bellardie,Haydn, AU - Mooney,Jeanette, AU - Mølsted,Kirsten, AU - Sæle,Paul, AU - Eyres,Phil, AU - Semb,Gunvor, PY - 2019/10/6/pubmed PY - 2020/3/4/medline PY - 2019/10/6/entrez SP - 15 EP - 23 JF - European journal of orthodontics JO - Eur J Orthod VL - 42 IS - 1 N2 - BACKGROUND: The Scandcleft international multicenter study is a prospective clinical trial of the long-term outcome after four different surgical protocols for palatal closure in patients born with unilateral cleft lip and palate (UCLP). This paper is one of a series of follow-up studies in 8-year olds. OBJECTIVES: To evaluate the dental occlusion of 8-year-old patients after four different protocols of primary surgery for UCLP. TRIAL DESIGN: Ten cleft centres in five countries tested three different surgical procedures for primary palatal repair in three parallel trials (Arms B, C, and D) against a common procedure (Arm A). METHODS: Initially 448 children born with non-syndromic UCLP were included in the project. At 8 years of age, 428 children remained in the study. Dental casts of 411 patients (270 boys, 141 girls), mean age 8.1 years (range 7.0-10.0) were taken. The casts were blindly assessed with the Modified Huddart and Bodenham (MHB) index by four orthodontists. The main outcome measures were anterior (+2 to -6) and posterior (0 to -8) mean scores. Comparisons were made with previous data in 5-year-olds. RESULTS: The inter- and intra-examiner reliability was good to excellent (0.75-0.90; 0.73-0.97), respectively. The mean total scores varied from -7.09 (Trial 2C) to -10.13 (Trial 3D). The mean anterior scores varied from -1.75 (Trial 2C) to -3.18 (Trial 1A). The mean posterior cleft-side scores varied from -4.32 (Trial 1B) to -5.21 (Trial 3D) and the mean non-cleft-side scores varied from -0.88 (Trial 2C) to -2.40 (Trial 3A). No significant differences were found within the trials. A significant difference was found between Trials 2 and 3 (Arm C/D) for the total score (P = 0.004). CONCLUSIONS: There was no evidence of clinically significant differences in occlusion between the two surgical methods in each trial or between the trials. All mean scores showed more negative values in 8-year-olds compared with previously reported values in 5-year-olds. TRIAL REGISTRATION: ISRCTN29932826. SN - 1460-2210 UR - https://www.unboundmedicine.com/medline/citation/31586176/Scandcleft_randomized_trials_of_primary_surgery_for_unilateral_cleft_lip_and_palate:_occlusion_in_8_year_olds_according_to_the_Modified_Huddart_and_Bodenham_index_ L2 - https://academic.oup.com/ejo/article-lookup/doi/10.1093/ejo/cjz077 DB - PRIME DP - Unbound Medicine ER -