Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars
Clinical Performance of Orthodontic Bands in the Restorative Treatment of Hypomineralised Primary Second Molars: a Randomised Clinical Trial
研究概览
地位
条件
详细说明
Hypomineralised second primary molars are more susceptible to post-eruptive enamel breakdown, carious lesions, hypersensitivity, and premature tooth loss. Although preformed stainless steel crowns have demonstrated favourable clinical performance in primary molars, orthodontic bands may represent a less invasive restorative approach for maintaining affected teeth until physiological exfoliation. However, their clinical performance in hypomineralised primary teeth has not been investigated.
This parallel-group randomised clinical trial will include 30 children presenting at least one hypomineralised second primary molar with extensive post-eruptive enamel breakdown or a cavitated carious lesion requiring restorative treatment. Participants will be randomly allocated to receive either an orthodontic band cemented with glass ionomer luting cement after restoration of the cavitated lesion or a preformed stainless steel crown placed using the Hall technique. When more than one tooth is eligible, one index tooth will be randomly selected for the primary analysis.
Clinical assessments will be performed immediately after treatment and at 6, 12, and 18 months. Marginal adaptation, retention, and carious lesions adjacent to the restoration margins will be assessed using modified United States Public Health Service criteria. Biofilm accumulation will be assessed using the Silness and Löe Plaque Index. Treatment acceptability will be evaluated immediately after treatment using separate questionnaires for children and caregivers. Physiological exfoliation during follow-up will be recorded separately and will not be considered treatment failure.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Rio Grande do Norte
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Natal、Rio Grande do Norte、巴西、59056-000
- 招聘中
- Federal University of Rio Grande do Norte
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接触:
- Lavínia L. Costa, Master's
- 电话号码:+55 84 998987405
- 邮箱:lavinialourencocosta@gmail.com
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria:
- Children aged 5-10 years.
- Presence of at least one second primary molar affected by hypomineralised second primary molars requiring restorative treatment.
- Hypomineralisation associated with post-eruptive enamel breakdown involving more than one tooth surface or a cavitated carious lesion involving more than one surface and classified as code 5 or 6 according to the International Caries Detection and Assessment System.
Exclusion Criteria:
- Extensive carious lesion with subgingival margins.
- Clinical or radiographic signs of pulpal inflammation or necrosis.
- Advanced physiological root resorption indicating imminent exfoliation of the eligible tooth.
- Previous restorative treatment of the eligible tooth.
- Presence of bruxism.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Bands
Participants allocated to this arm will receive selective removal of softened carious dentine when carious tissue is present, followed by restoration of the cavity with conventional glass ionomer restorative cement (GC Gold Label 9).
A prefabricated stainless steel orthodontic band will then be adapted to the index tooth and cemented with glass ionomer luting cement (Meron).
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Selective removal of softened carious dentine, when present, followed by restoration with conventional glass ionomer cement and placement of a prefabricated stainless steel orthodontic band cemented with glass ionomer luting cement.
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有源比较器:Crowns
articipants allocated to this arm will receive a preformed stainless steel crown placed using the Hall technique, without caries removal, local anaesthesia, or tooth preparation.
When a large cavity is present, glass ionomer restorative cement (GC Gold Label 9) will be placed at its base without prior caries removal.
The crown will be cemented with glass ionomer luting cement (Meron).
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Placement of a preformed stainless steel crown using the Hall technique, without caries removal, local anaesthesia, or tooth preparation.
The crown will be cemented with glass ionomer luting cement.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Marginal adaptation
大体时间:18 months after treatment
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Marginal adaptation will be assessed using modified United States Public Health Service criteria: Alpha, continuous margin without a detectable gap; Bravo, minor discontinuity not requiring clinical intervention; and Charlie, marginal defect requiring repair or replacement.
Alpha and Bravo will be considered clinically satisfactory, whereas Charlie will be considered a failure.
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18 months after treatment
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Retention
大体时间:18 months after treatment
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Retention will be classified as Alpha when the orthodontic band or stainless steel crown remains firmly cemented and functional, or Charlie when it is lost or dislodged and requires recementation or replacement.
Alpha will be considered successful retention and Charlie a failure.
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18 months after treatment
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Presence of carious lesions
大体时间:18 months after treatment
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Carious lesions adjacent to the restoration margins will be assessed clinically and classified as Alpha when absent or Charlie when present.
Alpha will be considered clinically satisfactory and Charlie a failure.
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18 months after treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Biofilm accumulation
大体时间:Immediately after treatment and at 6, 12, and 18 months
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Biofilm accumulation will be assessed using the Silness and Löe Plaque Index, ranging from 0 to 3: 0, absence of biofilm; 1, thin biofilm film along the free gingival margin; 2, moderate accumulation within the gingival sulcus; and 3, abundant accumulation within the gingival sulcus.
Lower scores indicate less biofilm accumulation.
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Immediately after treatment and at 6, 12, and 18 months
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Child-reported treatment acceptability
大体时间:Immediately after treatment
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Acceptability will be assessed using a five-item questionnaire.
Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20.
The negatively worded item will be reverse-scored.
Higher total scores indicate greater treatment acceptability.
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Immediately after treatment
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Caregiver-reported treatment acceptability
大体时间:Immediately after treatment
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Acceptability will be assessed using a five-item questionnaire.
Each item will be scored from 0 to 4, resulting in a total score ranging from 0 to 20.
Higher total scores indicate greater treatment acceptability.
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Immediately after treatment
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合作者和调查者
出版物和有用的链接
一般刊物
- Bekes K, Steffen R, Kramer N. Hypomineralised second primary molars: the Wurzburg concept. Eur Arch Paediatr Dent. 2024 Aug;25(4):597-602. doi: 10.1007/s40368-024-00913-7. Epub 2024 May 28.
- Talekar AL, Waggoner WF, Silotry TMH, Musale PK, Chaudhari GS. Prospective, Randomized, Clinical Evaluation of Preformed Zirconia Crowns and Stainless Steel Crowns on Permanent First Molars: 12-Month Results. Pediatr Dent. 2023 May 15;45(3):232-239.
- Bagattoni S, Gozzi I, Lunardon C, Gatto MR, Piana G, Lardani L. Orthodontic Bands for Preventing Post-Eruptive Breakdown in Molars Affected by Molar Incisor Hypomineralisation. Eur J Paediatr Dent. 2025 Sep 1;26(3):212-217. doi: 10.23804/ejpd.2025.2380. Epub 2025 Apr 1.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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