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Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds.
J Plast Surg Hand Surg. 2017 Feb; 51(1):52-57.JP

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.

Authors+Show Affiliations

a Department of Plastic Surgery, Cleft Palate and Craniofacial Center , Helsinki University Hospital , Helsinki , Finland.b Cleft Palate Center , Aarhus , Denmark.c Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet , Oslo , Norway.d Dental School, University of Manchester , Manchester , UK.e Copenhagen Cleft Palate Center , University Hospital of Copenhagen , Denmark.f Division of Orthodontics, Department of Dental Medicine, Stockholm Craniofacial Team , Karolinska Institutet , Stockholm , Sweden.c Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet , Oslo , Norway.g Orthodontic clinic , University Clinics of Odontology Gothenburg , Sweden.h Dentofacial Orthopedics, Maxillofacial Unit , University Hospital , Linköping , Sweden.i Oral Health Center of Excellence/Western Norway , Bergen , Norway.a Department of Plastic Surgery, Cleft Palate and Craniofacial Center , Helsinki University Hospital , Helsinki , Finland.c Department of Plastic and Reconstructive Surgery , Oslo University Hospital, Rikshospitalet , Oslo , Norway.g Orthodontic clinic , University Clinics of Odontology Gothenburg , Sweden.j Greater Manchester Cleft Unit, Royal Manchester Children's Hospital , Manchester , UK.j Greater Manchester Cleft Unit, Royal Manchester Children's Hospital , Manchester , UK.d Dental School, University of Manchester , Manchester , UK.k Dental School, University of Manchester , Manchester , UK. l Department of Plastic and Reconstructive Surgery, Oslo University Hospital, Rikshospitalet and Statped Sørøst , Oslo , Norway.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

27778528

Citation

Heliövaara, Arja, et al. "Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate: 6. Dental Arch Relationships in 5 Year-olds." Journal of Plastic Surgery and Hand Surgery, vol. 51, no. 1, 2017, pp. 52-57.
Heliövaara A, Küseler A, Skaare P, et al. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds. J Plast Surg Hand Surg. 2017;51(1):52-57.
Heliövaara, A., Küseler, A., Skaare, P., Shaw, W., Mølsted, K., Karsten, A., Brinck, E., Rizell, S., Marcusson, A., Sæle, P., Hurmerinta, K., Rønning, E., Najar Chalien, M., Bellardie, H., Mooney, J., Eyres, P., & Semb, G. (2017). Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds. Journal of Plastic Surgery and Hand Surgery, 51(1), 52-57. https://doi.org/10.1080/2000656X.2016.1221352
Heliövaara A, et al. Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate: 6. Dental Arch Relationships in 5 Year-olds. J Plast Surg Hand Surg. 2017;51(1):52-57. PubMed PMID: 27778528.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds. AU - Heliövaara,Arja, AU - Küseler,Annelise, AU - Skaare,Pål, AU - Shaw,William, AU - Mølsted,Kirsten, AU - Karsten,Agneta, AU - Brinck,Eli, AU - Rizell,Sara, AU - Marcusson,Agneta, AU - Sæle,Paul, AU - Hurmerinta,Kirsti, AU - Rønning,Elisabeth, AU - Najar Chalien,Midia, AU - Bellardie,Haydn, AU - Mooney,Jeanette, AU - Eyres,Phil, AU - Semb,Gunvor, Y1 - 2016/10/25/ PY - 2016/10/26/pubmed PY - 2017/12/16/medline PY - 2016/10/26/entrez KW - Randomised control trials KW - Scandcleft KW - dental arch relationship KW - dental model (cast) KW - intercentre study KW - the 5-year index KW - unilateral cleft lip and palate SP - 52 EP - 57 JF - Journal of plastic surgery and hand surgery JO - J Plast Surg Hand Surg VL - 51 IS - 1 N2 - 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. SN - 2000-6764 UR - https://www.unboundmedicine.com/medline/citation/27778528/Scandcleft_randomised_trials_of_primary_surgery_for_unilateral_cleft_lip_and_palate:_6__Dental_arch_relationships_in_5_year_olds_ L2 - http://www.tandfonline.com/doi/full/10.1080/2000656X.2016.1221352 DB - PRIME DP - Unbound Medicine ER -