跳至主要内容
临床试验/NCT04002999
NCT04002999Unknown不适用

Precision Orthodontics: Customized Versus Conventional Orthodontic Bracket Prescriptions - A Randomized Controlled Clinical Trial

Harvard School of Dental Medicine2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年8月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
51
试验地点
2
主要终点
Quality of first stage of orthodontic finish: Objective Grading System (OGS)

研究概览

简要总结

The investigators are evaluating the effectiveness of custom-made 3D-printed ceramic (tooth-colored) brackets (braces) compared to conventional tooth-colored brackets (braces).

Participants will be expected to come in for regularly scheduled appointments. They will be treated with tooth-colored braces and will need to come in every 4-6 weeks and will be randomly assigned to one of three groups. "Randomly" means by chance, like a coin toss. Neither participants nor the researchers may choose group assignments. Group 1 patients will have tooth-colored braces placed directly on each tooth by the clinician. Group 2 patients will have the braces placed on the teeth by using trays to fit them on. Group 3 patients will have customized 3D printed tooth-colored braces placed on their teeth, using trays to fit them on. If a participant is selected to be part of group 3, it may take up to two additional weeks for these 3D brackets to be printed and shipped and so this might delay treatment onset. Information on gender, age, and medical history of participants will also be obtained from the electronic health record.

详细描述

Teeth and orthodontic treatment plans are very unique to the specific patient, yet standard orthodontic braces are currently "one-size fits all". In the early 20th century, orthodontics was practiced using non-programmed brackets. First, second and third order bends had to be incorporated into the wire in order to achieve ideal final tooth positions.

Andrews' Straight Wire Appliance (SWA) in the 1970s, however, revolutionized orthodontic care by presenting a standard set of brackets with pre-programmed prescriptions built into the appliance system [5-7]. According to Andrews, "it is far easier to control tooth movement with bracket placement than bending wires".

Andrews analyzed 120 patient cases which presented with what he described as an ideal occlusion. He documented common characteristics in regard to angulation, tip, and torque subjectively deemed to create an ideal occlusion. This allowed him to develop a bracket prescription to compensate for the disparity in the contour of the facial surfaces of teeth by increasing thickness of the bracket base. Furthermore, he introduced angulations within the bracket slot to achieve proper positioning of the roots [5, 8]. This "straight-wire appliance" (SWA) method became widely accepted in orthodontics, and numerous variations of pre-adjusted bracket systems have since been introduced. Pre-adjusted brackets, however, fail to address deviations from average tooth morphology and other treatment nuances. These are often tackled chairside by placing bends on arch wires [9-12] - bends that the SWA method was invented to prevent. Additionally, mechanical boundaries and imprecision of bracket placement can result in limitations to treatment. [13-15] All these inaccuracies may cumulate during the course of a treatment to increase treatment time, resulting in frustration and compromised results.

Technological advancements have allowed for some customization of brackets and wires in order to address limitations of conventional pre-adjusted bracket systems. Digital intra-oral scans are obtained at the onset of treatment to generate a digital study model of the dentition. Virtual models are analyzed to determine the ideal position of each tooth required for achieving stable occlusion. Those digital models also allow for bracket positioning set-up; indirect-bonding transfer jigs allow virtual positioning to be replicated intra-orally. The clinician creates a virtual design of the final occlusion and alignment using computer-assisted technology, with reverse-engineered brackets and archwires used to obtain the intended result. Bracket slots are customized to accommodate a straight wire that moves each tooth to the ideal final position as identified by the virtual setup. Virtual bracket positions are then transferred to the patient by means of indirect-bonding transfer jigs [16].

Several orthodontic systems implement some of these new technologies, [17] providing the orthodontist with a treatment package consisting of digital diagnostics, 3-dimensional (3D) digital planning, and computer-designed customized brackets and arch wires. One such system is the Insignia (ORMCO Corporation) system [18], which entered the market several years ago. Theoretically, individualized orthodontic treatment systems offer several advantages for both the patient and orthodontist, with commonly mentioned benefits including better treatment results, shorter treatment duration, and less chair time. [19] Manufacturers utilizing virtual treatment planning and customized, computer-aided fabrication of tooth supported orthodontic appliances claim to deliver superior quality and efficiency of care compared to conventional preadjusted bracket systems. To date, few studies have investigated the accuracy of these systems in achieving their virtually planned tooth positions.

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 (Investigator)

入排标准

年龄范围
11 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subjects over the age of 10 years and below 65;
  • Eruption of all permanent teeth excluding second and third molars;
  • Non-extraction treatment;
  • Maximum of 7mm of crowding/spacing;
  • No more than 45 degrees of rotations

排除标准

  • Presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars); congenitally missing teeth, and tumors of the parathyroid gland;
  • The presence of bridges or implants;
  • Significant (> moderate) periodontal disease, intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal Anti-Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class), pregnancy; and
  • Cases requiring tooth extractions

结局指标

主要结局

Quality of first stage of orthodontic finish: Objective Grading System (OGS)

时间窗: 12months

A number of measures have been developed to determine the quality of orthodontic treatment. The Objective Grading System (OGS), \[27\] developed by the American Board of Orthodontics (ABO) in 1994, was designed to establish a uniform and objective evaluation of cases

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验