| 1. |
- Botticelli, Susanna, et al.
(författare)
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Do Infant Cleft Dimensions Have an Influence on Occlusal Relations? A Subgroup Analysis Within an RCT of Primary Surgery in Patients With Unilateral Cleft Lip and Palate
- 2020
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Ingår i: The Cleft Palate-Craniofacial Journal. - : Sage Publications. - 1055-6656 .- 1545-1569. ; 57:3, s. 378-388
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Tidskriftsartikel (refereegranskat)abstract
- Aim: To investigate whether infant cleft dimensions, in a surgical protocol with early or delayed hard palate closure, influence occlusion before orthodontics.less thanbr /greater thanDesign: Subgroup analysis within a randomized trial of primary surgery (Scandcleft).less thanbr /greater thanSetting: Tertiary health care. One surgical centre.less thanbr /greater thanPatients and Methods: A total of 122 unilateral cleft lip and palate infants received primary cheilo-rhinoplasty and soft palate closure at age 4 months and were randomized for hard palate closure at age 12 versus 36 months. A novel 3D analysis of cleft size and morphology was performed on digitized presurgical models. Occlusion was scored on 8-year models using the modified Huddarth-Bodenham (MHB) Index and the Goslon Yardstick.less thanbr /greater thanMain Outcome Measurements: Differences in MHB and Goslon scores among the 2 surgical groups adjusted for cleft size.less thanbr /greater thanResults: The crude analysis showed no difference between the 2 surgical groups in Goslon scores but a better MHB (P = .006) for the group who received delayed hard palate closure. When adjusting for the ratio between cleft surface and palatal surface (3D Infant Cleft Severity Ratio) and for posterior cleft dimensions at tuberosity level, the delayed hard palate closure group received 3.65 points better for MHB (confidence interval: 1.81; 5.48; P less than .001) and showed a trend for reduced risk of receiving a Goslon of 4 or 5 (P = .052). For posterior clefts larger than 9 mm, the Goslon score was better in the delayed hard palate closure group (P = .033).less thanbr /greater thanConclusions: Seen from an orthodontic perspective, when the soft palate is closed first, and the cleft is large, the timing of hard palate closure should be planned in relation to posterior cleft size.
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| 2. |
- Heliövaara, Arja, et al.
(författare)
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Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 6. Dental arch relationships in 5 year-olds.
- 2017
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Ingår i: Journal of plastic surgery and hand surgery. - : Taylor & Francis. - 2000-6764 .- 2000-656X. ; 51:1, s. 52-57
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Tidskriftsartikel (refereegranskat)abstract
- 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.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.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.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).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.ISRCTN29932826.
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| 3. |
- Heliövaara, Arja, et al.
(författare)
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Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate : comparison of dental arch relationships and dental indices at 5, 8, and 10 years
- 2022
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Ingår i: European Journal of Orthodontics. - : Oxford University Press. - 0141-5387 .- 1460-2210. ; 44:3, s. 258-267
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Tidskriftsartikel (refereegranskat)abstract
- Background and trial design The Scandcleft intercentre study evaluates the outcomes of four surgical protocols (common method Arm A, and methods B, C, and D) for treatment of children with unilateral cleft lip and palate (UCLP) in a set of three randomized trials of primary surgery (Trials 1, 2, and 3). Objectives To evaluate and compare dental arch relationships of 5-, 8-, and 10-year-old children with UCLP after four different protocols of primary surgery and to compare three dental indices. The results are secondary outcomes of the overall trial. Methods Study models taken at the ages of 5 (n = 418), 8 (n = 411), and 10 years (n = 410) were analysed by a blinded panel of orthodontists using the Eurocran index, the 5-year-olds (5YO) index, and the GOSLON Yardstick. Students t-test, Pearsons correlation, chi-square test, and kappa statistics were used in statistical analyses. Results The reliability of the dental indices varied between moderate and very good, and those of the Eurocran palatal index varied between fair and very good. Significant correlations existed between the dental indices at all ages. No differences were found in the mean 5-, 8-, and 10-year index scores or their distributions within surgical trials. Comparisons between trials detected significantly better mean index scores in Trial 2 Arm C (at all ages) and in Trial 1 Arm B (at 5 and 10 years of age) than in Trial 3 Arm D. The mean Eurocran dental index scores of the total material at 5, 8, and 10 years of age were 2.50, 2.60, and 2.26, and those of the 5YO index and GOSLON Yardstick were 2.77, 2.90, and 2.54, respectively. At age 10 years, 75.8% of the patients had had orthodontic treatment. Conclusions The results of these three trials do not provide evidence that one surgical method is superior to the others. The reliabilities of the dental indices were acceptable, and significant correlations existed between the indices at all ages. The reliability of the Eurocran palatal index was questionable.
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| 4. |
- Heliövaara, Arja, et al.
(författare)
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Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: comparison of dental arch relationships and dental indices at 5, 8, and 10 years.
- 2022
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Ingår i: European journal of orthodontics. - : Oxford University Press. - 1460-2210 .- 0141-5387. ; 44:3
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Tidskriftsartikel (refereegranskat)abstract
- The Scandcleft intercentre study evaluates the outcomes of four surgical protocols (common method Arm A, and methods B, C, and D) for treatment of children with unilateral cleft lip and palate (UCLP) in a set of three randomized trials of primary surgery (Trials 1, 2, and 3).To evaluate and compare dental arch relationships of 5-, 8-, and 10-year-old children with UCLP after four different protocols of primary surgery and to compare three dental indices. The results are secondary outcomes of the overall trial.Study models taken at the ages of 5 (n = 418), 8 (n = 411), and 10 years (n = 410) were analysed by a blinded panel of orthodontists using the Eurocran index, the 5-year-olds' (5YO) index, and the GOSLON Yardstick. Student's t-test, Pearson's correlation, chi-square test, and kappa statistics were used in statistical analyses.The reliability of the dental indices varied between moderate and very good, and those of the Eurocran palatal index varied between fair and very good. Significant correlations existed between the dental indices at all ages. No differences were found in the mean 5-, 8-, and 10-year index scores or their distributions within surgical trials. Comparisons between trials detected significantly better mean index scores in Trial 2 Arm C (at all ages) and in Trial 1 Arm B (at 5 and 10 years of age) than in Trial 3 Arm D. The mean Eurocran dental index scores of the total material at 5, 8, and 10 years of age were 2.50, 2.60, and 2.26, and those of the 5YO index and GOSLON Yardstick were 2.77, 2.90, and 2.54, respectively. At age 10 years, 75.8% of the patients had had orthodontic treatment.The results of these three trials do not provide evidence that one surgical method is superior to the others. The reliabilities of the dental indices were acceptable, and significant correlations existed between the indices at all ages. The reliability of the Eurocran palatal index was questionable.ISRCTN29932826.
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| 5. |
- Heliövaara, Arja, et al.
(författare)
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Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate. Dental arch relationships in 8 year-olds.
- 2020
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Ingår i: European journal of orthodontics. - : Oxford University Press (OUP). - 1460-2210 .- 0141-5387. ; 42:1, s. 1-7
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Tidskriftsartikel (refereegranskat)abstract
- 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).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.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.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.The results of these three trials do not provide evidence that one surgical protocol is better than the others.ISRCTN29932826.
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| 6. |
- Karsten, Agneta, et al.
(författare)
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Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 7. Occlusion in 5 year-olds according to the Huddart and Bodenham index.
- 2017
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Ingår i: Journal of Plastic Surgery and Hand Surgery. - : Taylor & Francis. - 2000-656X .- 2000-6764. ; 51:1, s. 58-63
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Tidskriftsartikel (refereegranskat)abstract
- Background and aim:Good dentofacial development and good occlusion are main goals in the treatment of UCLP. The aim was to evaluate dental occlusion at age 5 years with the Huddart and Bodenham index after four different protocols of primary surgery for UCLP. Design:Three parallel randomised controlled trials were undertaken as an international multicentre 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, and D) were tested against a common procedure (Arm A) in the total cohort of 448 children born with non-syndromic UCLP. Dental casts of 418 patients (272 boys, 146 girls), at the mean age of 5.1 years (range =4.7–6.9) were blindly assessed by 10 orthodontists with the original Huddart and Bodenham index. The main outcome measure was dental occlusion. Results:The inter- and intra-examiner reliability was good-to-excellent (0.61–0.94; 0.66–1.0, respectively). The mean total scores (+2 to −18) varied from −5.56 (Trial 2C) to −7.21 (Trial 3D). The mean anterior scores (+2 to −6) varied from −1.66 (Trial 2C) to −2.56 (Trial 3A). The mean posterior cleft-side scores (0 to −6) varied from −3.24 (Trial 3A) to −3.82 (Trial 3D) and the mean non-cleft-side scores (0 to −6) varied from −0.60 (Trial 2C) to −1.30 (Trial 3A); however, no significant differences were found within the trials. Conclusion:There was no statistical evidence of a difference in occlusion between the two surgical methods in each trial. Trial registration:ISRCTN29932826. [ABSTRACT FROM AUTHOR]
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| 7. |
- Karsten, Agneta, et al.
(författare)
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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.
- 2020
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Ingår i: European journal of orthodontics. - : Oxford University Press (OUP). - 1460-2210 .- 0141-5387. ; 42:1, s. 15-23
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Tidskriftsartikel (refereegranskat)abstract
- 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.To evaluate the dental occlusion of 8-year-old patients after four different protocols of primary surgery for UCLP.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).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.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).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.ISRCTN29932826.
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| 8. |
- Kristensen, Kasper Dahl, et al.
(författare)
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Signs and symptoms after temporomandibular joint washing and cannula placement assessed by cone beam computerized tomography
- 2015
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Ingår i: Acta Odontologica Scandinavica. - : Taylor & Francis. - 0001-6357 .- 1502-3850. ; 73:6, s. 454-460
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Analyses of temporomandibular joint synovial fluid using the hydroxocobalamin push-pull technique are increasingly used. However, objective complications and subjective experiences from this procedure have not been described. Firstly, this study aimed to describe discomfort and potential side-effects of this method with special emphasis on symptoms related to the arthrocentesis to be used for future patient information and Ethical Committee applications. Secondly, this study aimed to evaluate the use of cone beam computed tomography (CBCT) as control of intra-capsular cannula placement. METHODS: Twenty healthy, young adult volunteers were included. Extensive objective and subjective questionnaires were completed before and 14 days after the synovial fluid sampling. With the cannula inside the joints a CBCT was done to investigate if this procedure can be used to verify intra-capsular cannula position. RESULTS: The subjective findings: Most subjects did experience mild pain or discomfort post-operatively. In 12 of 20 subjects symptoms had resolved after 2 days and no subjects had symptoms for more than a week. The longer lasting symptoms were mainly transient joint sounds on mandibular movement. Objective findings: 14 days after the sampling mandibular protrusion had improved 1 mm, but all other objective measures were equal compared to baseline. CBCT showed a large variation in cannula position and no conclusions could be drawn from this. CONCLUSION: The hydroxocobalamin push-pull synovial fluid sampling may cause minor, transient symptoms. CBCT does not seem to provide any clinical benefits concerning the correct cannula position in relation to the upper joint compartment and disc
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| 9. |
- Küseler, Annelise, et al.
(författare)
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Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: maxillary growth at eight years of age
- 2020
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Ingår i: European Journal of Orthodontics. - : Oxford University Press. - 0141-5387 .- 1460-2210. ; 42:1, s. 24-29
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Tidskriftsartikel (refereegranskat)abstract
- 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.less thanbr /greater thanDesign 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.less thanbr /greater thanSubjects 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.less thanbr /greater thanResults: 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.less thanbr /greater thanConclusions: The timing and the surgical method is not of major importance as far as growth outcomes (SNA and ANB) in UCLP are concerned.less thanbr /greater thanRegistration: ISRCTN29932826.less thanbr /greater thanProtocol: The protocol was not published before trial commencement.less thanbr /greater than (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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| 10. |
- Küseler, Annelise, et al.
(författare)
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Scandcleft randomized trials of primary surgery for unilateral cleft lip and palate: maxillary growth at eight years of age.
- 2020
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Ingår i: European journal of orthodontics. - : Oxford University Press (OUP). - 1460-2210 .- 0141-5387. ; 42:1, s. 24-29
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Tidskriftsartikel (refereegranskat)abstract
- To assess differences in craniofacial growth at 8 years of age according to the different protocols for primary cleft surgery in the Scandcleft project.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.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.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.The timing and the surgical method is not of major importance as far as growth outcomes (SNA and ANB) in UCLP are concerned.ISRCTN29932826.The protocol was not published before trial commencement.
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