Miniscrews as Anchorage Device for Orthodontic Treatment - Randomized Controlled Trials on Anchorage Capacity, Cost Efficiency and Patient Acceptance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Tooth Position of the Maxillary Molars During Space Closure
研究概览
简要总结
The purpose of this trial is to study and compare two different anchorage techniques. Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both groups are treated with extractions of the maxillary first premolars and fixed appliance. Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.
The hypotheses are:
- that placement of miniscrews does not cause more pain or discomfort than premolar extractions
- that molarblock provides increase of anchorage
- that miniscrews have a better anchorage capacity than molarblock
- that miniscrews are more cost-efficient than conventional anchorage techniques
详细描述
Participants are recruited from the orthodontic specialist clinic in Gävle, Sweden. After informed consent participants are randomized into Group A and B. The treatment starts with extractions of the maxillary first premolars. Extractions are performed by the participants´ general practitioner. Orthodontic treatment starts after the tooth extractions.
All participants get treatment with fixed appliance according to the straight wire concept (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription). The recommended wire sequence is: .016 Heat Activated Nickel Titanium, .019x.025 Heat Activated Nickel Titanium, .019x.025 Stainless Steel. Treatment time is about two years.
The following measurements are taken at:
T0 (Before treatment start): Study models, baseline questionnaire,
T1 (after tooth extractions, before the orthodontic treatment): Study models, cephalographic x-ray, questionnaire at the evening after tooth extractions, questionnaire one week after tooth extractions.
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)
入排标准
- 年龄范围
- 11 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adolescents in need of orthodontic treatment with fixed appliance including extractions of the maxillary first premolars
- •Need for Anchorage reinforcement
- •Permanent dentition including the maxillary second molars in occlusion (DS4M2 according to Björk)
- •Regular dental care in Sweden since the age of three.
排除标准
- •Experience of previous orthodontic treatment
- •Need for orthognathic surgery
- •Need for maximum anchorage.
研究组 & 干预措施
Group A - Miniscrews
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs.
干预措施: Topical anesthesia (buccal and palatal) (Drug)
Group A - Miniscrews
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs.
干预措施: Local anesthesia (buccal and palatal) (Drug)
Group A - Miniscrews
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs.
干预措施: Extraction of the maxillary first premolars (Procedure)
Group A - Miniscrews
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs.
干预措施: Topical anesthesia (buccal) (Drug)
Group A - Miniscrews
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs.
干预措施: Local anesthesia (buccal) (Drug)
Group A - Miniscrews
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs.
干预措施: Spider Screw K1 short neck (Device)
Group B - Molarblock
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal. Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with molarblocks - a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. Molarblocks are installed from the beginning of leveling and alignment. Space closure is performed as en masse retraction with type one active tie-backs.
干预措施: Topical anesthesia (buccal and palatal) (Drug)
Group B - Molarblock
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal. Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with molarblocks - a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. Molarblocks are installed from the beginning of leveling and alignment. Space closure is performed as en masse retraction with type one active tie-backs.
干预措施: Local anesthesia (buccal and palatal) (Drug)
Group B - Molarblock
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal. Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with molarblocks - a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. Molarblocks are installed from the beginning of leveling and alignment. Space closure is performed as en masse retraction with type one active tie-backs.
干预措施: Extraction of the maxillary first premolars (Procedure)
Group B - Molarblock
Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal. Extraction of the maxillary first premolars.
Fixed appliance in the maxilla or maxilla and mandible.
Anchorage reinforcement with molarblocks - a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. Molarblocks are installed from the beginning of leveling and alignment. Space closure is performed as en masse retraction with type one active tie-backs.
干预措施: Molarblock (Device)
结局指标
主要结局
Change in Tooth Position of the Maxillary Molars During Space Closure
时间窗: Through Space Closure (T2-T3), an average of 9 months
Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.
次要结局
- Experience of Pain and Discomfort(Baseline, the evening after tooth extractions, one week after tooth extractions, the evening after miniscrew placement, one week after miniscrew placement)
- Change in Tooth Position of the Maxillary Molars During Levelling and Alignment(Through Levelling and Alignment (T1-T2), an average of 9 months)
- Societal Costs(Through Study Completion, an average of 2 years)
研究者
Niels Ganzer
DDS, Senior Consultant Orthodontist
Region Gävleborg