Reducing the burden of orthodontic care for children with clefts: evaluating the effectiveness of pre-alveolar bone graft orthodontics in unilateral non-syndromic cleft patients (PABO study)- A study protocol for a multicentric randomised controlled trial.
Reducing the burden of orthodontic care for children with clefts: evaluating the effectiveness of pre-alveolar bone graft orthodontics in unilateral non-syndromic cleft patients (PABO study)- A study protocol for a multicentric randomised controlled trial.
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DOI：
10.1186/s13063-021-05505-0
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发表时间：
2021-08-28
期刊：
影响因子：
2.5
通讯作者：
Prathap C M
中科院分区：
文献类型：
--
作者：
Thiruvenkatachari B;Hussain SA;Batra P;Vijayakumar C;Prathap C M
牙槽裂通常影响75%的唇腭裂患者。虽然在牙槽骨移植之前提供一个正畸治疗过程是常见的做法，但以前没有高质量的研究报告这种治疗的好处。本研究的目的是评估单侧非综合征性腭裂患者牙槽前植骨的有效性。PABO试验是一项多中心、平行、双臂、单盲、随机对照试验。纳入标准包括需要植骨的单侧牙槽嵴裂患者，年龄在8岁至13岁之间，有上中切牙萌出。参与者将在印度的三个中心招募。受试者将被随机分配到正畸治疗组或无正畸治疗组。两组受试者都将接受牙槽骨移植手术，并将在术后随访6个月。主要结果将是通过前斜位X线片测量的牙槽骨移植物的成功率，次要结果包括生活质量、成本分析和牙咬合结果的质量。研究结束时，将由独立统计学家进行数据分析。本研究首次评价了正畸治疗对牙槽骨移植成功率的影响。这些患者从出生到成年需要多名专家进行多种治疗，护理负担增加，这突出表明需要减少不必要的治疗。临床试验注册中心-印度，CTRI/2020/10/028756。试验于2020年10月29日前瞻性注册。.
An alveolar cleft commonly affects 75% of cleft lip and palate patients. While it is common practice to provide a course of orthodontic treatment before alveolar bone grafting, there are no previous high-quality studies reporting on the benefits of this type of treatment. The aim of the study is to evaluate the effectiveness of pre-alveolar bone graft orthodontics for unilateral non-syndromic cleft palate patients. The PABO trial is a multicentric, parallel, two-arm, single-blinded randomised controlled trial. The inclusion criteria include unilateral cleft alveolus patients requiring bone graft and between the age group of 8 and 13 years with erupted upper central incisors. Participants will be recruited at three centres across India. Participants will be randomised to orthodontic treatment or no orthodontic treatment group. Both groups of participants will have alveolar bone graft surgery and will be followed up for 6 months after surgery. The primary outcome will be the success of the alveolar bone graft measured by anterior oblique radiograph and secondary outcomes include quality of life, cost analysis and quality of the dento-occlusal outcome. Data analysis will be carried out by an independent statistician at the end of the study. This study is the first to evaluate the effect of orthodontics on alveolar bone graft success. The increased burden of care for these patients with multiple treatments required from multiple specialists from birth to adult life highlights the need for reducing unnecessary treatment provision. Clinical Trials Registry – India, CTRI/2020/10/028756. Trial prospectively registered on 29 October 2020. .
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DOI：
10.1016/0002-9416(76)90258-x
发表时间：
1976-01-01
影响因子：
3
作者：
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通讯作者：
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DOI：
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发表时间：
2009-10
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作者：
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影响因子：
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作者：
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通讯作者：
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发表时间：
2011-03
期刊：
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作者：
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通讯作者：
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