Digital Manufacturing and Periodontal Performance of CAD/CAM-Customized Orthodontic Molar Bands Compared With Standard Stainless-Steel Bands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in Plaque Control Record (PCR) between CAD/CAM-customized molar bands and standard stainless-steel molar bands
研究概览
简要总结
his prospective randomized clinical trial aimed to compare periodontal outcomes associated with CAD/CAM-customized orthodontic molar bands and conventional preformed stainless-steel molar bands in adolescents undergoing fixed orthodontic treatment. A total of 180 participants were randomly allocated into two groups: customized CAD/CAM bands (n = 90) and standard stainless-steel bands (n = 90). Periodontal parameters, including Plaque Control Record (PCR), Bleeding on Probing (BOP), and Periodontal Probing Depth (PPD), were evaluated at baseline, 1 month, 3 months, and 6 months. The primary objective was to assess whether customized bands improve periodontal health by reducing plaque accumulation and gingival inflammation during orthodontic therapy.
详细描述
Orthodontic molar bands are commonly fabricated from stainless-steel alloys and are widely used in fixed orthodontic therapy to provide anchorage for auxiliary appliances. However, conventional prefabricated bands are manufactured in standardized sizes and may not precisely adapt to individual tooth morphology. Inadequate adaptation may create plaque-retentive areas at the band-tooth interface, increasing the risk of gingival inflammation and early periodontal changes during orthodontic treatment.
Advances in digital dentistry have enabled the fabrication of customized orthodontic components using computer-aided design and computer-aided manufacturing (CAD/CAM) technologies. Digitally manufactured molar bands can be designed based on intraoral scans to achieve precise anatomical adaptation, potentially reducing marginal discrepancies and improving periodontal compatibility.
This prospective randomized controlled clinical study enrolled 180 adolescents requiring fixed orthodontic therapy involving molar bands. Participants were randomly assigned to receive either CAD/CAM-customized molar bands or conventional preformed stainless-steel molar bands. Customized bands were designed using digital intraoral scans and CAD software, then manufactured from cobalt-chromium alloy using high-precision milling and thermal sintering. Standard bands were selected from conventional size kits and manually adapted.
All bands were cemented using the same glass ionomer cement, and identical orthodontic appliances were used in both groups. Periodontal outcomes were assessed by a blinded examiner using standardized indices: Plaque Control Record (PCR), Bleeding on Probing (BOP), and Periodontal Probing Depth (PPD). Measurements were recorded at baseline, 1 month, 3 months, and 6 months.
The primary objective of the study was to evaluate differences in periodontal health between customized and conventional molar bands. Secondary objectives included assessing changes in plaque accumulation, gingival bleeding, and probing depth over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The orthodontist placing the molar bands was not blinded due to the nature of the interventions. However, periodontal measurements were performed by a calibrated examiner who was blinded to group allocation to reduce measurement bias.
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents requiring fixed orthodontic therapy involving molar bands Good general health with no systemic diseases affecting periodontal tissues Acceptable baseline oral hygiene Patient and guardian consent to participate Compliance with follow-up visits
排除标准
- •History of periodontal disease Current antibiotic or anti-inflammatory therapy Dental trauma affecting first molars Poor oral hygiene compliance during screening Systemic conditions affecting periodontal health
研究组 & 干预措施
CAD/CAM-Customized Molar Bands
ARM 1
Arm Description:
Participants received CAD/CAM-customized orthodontic molar bands designed using digital intraoral scans and computer-aided design software. Bands were manufactured from cobalt-chromium alloy using high-precision milling and thermal sintering and cemented as part of fixed orthodontic treatment.
Intervention: CAD/CAM-Customized Orthodontic Molar Bands
干预措施: Stainless-Steel Orthodontic Molar Bands (Device)
Standard Stainless-Steel Molar Bands
Participants received conventional preformed stainless-steel orthodontic molar bands selected from standard size kits and manually adapted before cementation as part of fixed orthodontic treatment.
Intervention: Standard Stainless-Steel Orthodontic Molar Bands
干预措施: Stainless-Steel Orthodontic Molar Bands (Device)
结局指标
主要结局
Change in Plaque Control Record (PCR) between CAD/CAM-customized molar bands and standard stainless-steel molar bands
时间窗: Baseline, 1 month, 3 months, and 6 months
Plaque Control Record (PCR) assessed on molar surfaces to evaluate plaque accumulation during orthodontic treatment.
次要结局
未报告次要终点
研究者
Sorana-Maria Bucur
Associate Professor
Dimitrie Cantemir University