Evaluation of the Biomechanical Response of Orthodontic Tooth Movement to Clear Aligner vs Fixed Orthodontic Appliance: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Interleukin-1β and Prostaglandin E2
研究概览
简要总结
Abstract
Background: Orthodontic tooth movement (OTM) is mediated by biologic responses of the periodontal ligament (PDL) and alveolar bone to applied mechanical forces, involving release of inflammatory mediators such as interleukin-1β (IL-1β) and prostaglandin E2 (PGE2) that promote osteoclast activation and bone remodeling. Intraoral biomarkers in gingival crevicular fluid (GCF) reflect these tissue changes and can be used to monitor inflammatory and metabolic responses during treatment. Digital technologies, including intraoral scanning and 3D superimposition, allow precise quantification of tooth movement over time.
Objective: This prospective, randomized comparative clinical study aims to compare the biological and mechanical responses of orthodontic tooth movement in patients treated with clear aligners versus conventional fixed appliances.
Methods: Twenty adult patients (aged 18-25 years) with mild dental crowding will be randomly assigned to either a fixed appliance group (n=10) or a clear aligner group (n=10). Baseline and follow-up GCF samples will be collected to quantify IL-1β and PGE2 using enzyme-linked immunosorbent assay (ELISA). Tooth mobility will be assessed using Periotest analysis, and 3D digital models obtained from intraoral scans will be superimposed to measure the amount of tooth movement over time. Secondary outcomes include clinical measures of mobility and patient-reported pain.
Expected Outcomes: It is anticipated that both treatment modalities will induce measurable increases in inflammatory biomarkers and tooth movement; however, differences in the magnitude and temporal patterns of IL-1β, PGE2, tooth mobility, and 3D-quantified displacement are expected due to the continuous forces of fixed appliances versus intermittent forces of aligners. Previous studies have shown that GCF cytokine levels rise with orthodontic force application in both aligner and fixed appliance treatments, with some variations between groups.
Conclusion: This study will provide new clinical evidence comparing biological mediator profiles and mechanical outcomes between clear aligners and fixed orthodontic appliances, improving understanding of tissue responses and informing clinical decision-making in contemporary orthodontic practice
详细描述
- Introduction
Orthodontic tooth movement (OTM) is a biologically mediated process that occurs as a response to mechanical forces applied to teeth. These forces should ideally be continuous and controlled, as they initiate cellular and molecular changes within the periodontal ligament (PDL) and surrounding alveolar bone. Mechanical loading results in vascular alterations within the PDL, followed by the release of inflammatory mediators that regulate bone modeling and remodeling. This cascade ultimately leads to osteoclastic bone resorption on the pressure side and osteoblastic bone formation on the tension side.
Gingival crevicular fluid (GCF) is a serum transudate or inflammatory exudate originating from the gingival sulcus and was first described by Alfano. It serves as a valuable, non-invasive medium for monitoring biochemical changes occurring in the periodontium during orthodontic treatment. GCF contains a variety of biologically active molecules, including proteins, cytokines, bacterial antigens, enzymes, electrolytes, and small organic compounds derived from both host tissues and oral microorganisms.
Application of orthodontic forces, particularly in the presence of plaque accumulation, induces a localized inflammatory response in periodontal tissues. This response is characterized by the activation and release of inflammatory cytokines such as matrix metalloproteinases (MMPs), interleukins (ILs), and tumor necrosis factor-alpha (TNF-α). Among these, Interleukin-1 (IL-1), particularly IL-1β, plays a central role in immune regulation and acute-phase inflammatory responses. During orthodontic tooth movement, IL-1β levels are significantly elevated in human gingival fibroblasts and GCF, reflecting increased osteoclastic activity.
Prostaglandin E2 (PGE2) is another key inflammatory mediator involved in orthodontic tooth movement. Elevated levels of IL-1β and PGE2 are typically observed during the early phase of orthodontic treatment. IL-1β promotes osteoclast differentiation and activation, while PGE2 acts synergistically to enhance bone resorption. Together, these mediators facilitate tooth movement and alveolar bone remodeling.
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
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Adult patients aged 18-25 years.
- •Skeletal class I mild dental crowding per arch (≤ 4 mm).
- •Good oral hygiene and no active periodontal disease.
- •Normal vertical SN-GOGN angle 32+- 3.
排除标准
- •• Patients with severe crowding or spacing (> 4 mm).
- •Presence of active dental caries or periodontal disease.
- •History of orthodontic treatment within the past two years.
- •Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- •Bimaxillary protrusion, sever proclination
研究组 & 干预措施
fixed orthodontic appliance
counting of Interleukin-1β and Prostaglandin E2 in gingival crevicular fluid, evaluation of the amount of tooth movement using intraoral scan and superimposition, tooth mobility using periotest devise and pain evaluation during orthodontic treatment
干预措施: diagnostic Test: Collection of GCF: from the gingival sulcus using paper point ,Tooth Mobility via Periotest ,3D Digital Model Superimposition using Intraoral Scanning (Diagnostic Test)
clear aligner appliance
counting of Interleukin-1β and Prostaglandin E2 in gingival crevicular fluid, evaluation of the amount of tooth movement using intraoral scan and superimposition, tooth mobility using periotest devise and pain evaluation during orthodontic treatment
干预措施: diagnostic Test: Collection of GCF: from the gingival sulcus using paper point ,Tooth Mobility via Periotest ,3D Digital Model Superimposition using Intraoral Scanning (Diagnostic Test)
结局指标
主要结局
Interleukin-1β and Prostaglandin E2
时间窗: 4 week
counting of Interleukin-1β and Prostaglandin E2 in gingival crevicular fluid
次要结局
- amount of tooth movement(4 weeks)
- tooth mobility(4 weeks)
- pain evaluation(2 weeks)
研究者
Mohamad Alamin
Principal investigator
Mansoura University