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临床试验/NCT03261024
NCT03261024Unknown不适用

Friction Versus Frictionless Mechanics During Maxillary En-masse Retraction in Adult Patients With Class I Bimaxillary Dentoalveolar Protrusion: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 30 人开始时间: 2017年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
主要终点
Duration of retraction

研究概览

简要总结

This study is a Randomized clinical trial comparing the effectiveness of two different mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly divided into two groups:Friction and frictionless mechanics. Mini screws will be used in both group to ensure maximum anchorage during retraction. Lateral cephalometric radiographs and dental models will be taken for each patients pre and post -retraction. Following complete anterior segment retraction, the rate and duration of retraction will be evaluated for both groups as well as patient satisfaction with treatment. Changes in incisors inclination and soft tissue as well as anchorage loss will be also assessed.

详细描述

Adult patients with Class I bimaxillary dentoalveolar protrusion will be recruited. All the patients need extraction of upper first premolars followed by anterior segment retraction and maximum anchorage.

The patients will be randomly allocated to one of two groups; either Friction or Frictionless group. In friction group, Nickel Titanium coil spring will be used for retraction of anterior segment while in frictionless group, T-loops will be used for retraction. All the patients will receive two miniscrews , one on each side to achieve maximum anchorage during retraction.

The patients will be seen on a monthly basis for follow up visit for activation of the appliance to maintain constant force during the study. An impression will be taken for the patients every visit, poured into stone for fabrication of dental models. The models will be used to monitor the rate of retraction of anterior teeth.

Every patient will be asked for lateral cephalometric radiograph before and after complete retraction. After data collection, two assessors will carry on the measurements blindly and independently. Statistical analysis of the data will be done and the results will be compared to evaluate the effectiveness of both techniques for en-masse retraction.

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
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female adult patients with age range 18-30 yrs old.
  • Class I bimaxillary dentoalveolar protrusion .
  • Full permanent dentition.
  • Good oral hygiene.
  • Maximum anchorage is required.
  • Healthy bone between first molars and second premolars is needed.

排除标准

  • Systemic disease.
  • Severe crowding.
  • Extracted or missing upper permanent tooth/teeth (except for third molars).
  • Any signs or symptoms or previous history of temporomandibular disorders (TMD).
  • Previous orthodontic treatment.

研究组 & 干预措施

Friction mechanics

Active Comparator

Upper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires.

Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally.

Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. Hook between upper laterals and canines will be fixed on the main archwire.

Nickel Titanium coil spring ( friction mechanics of retraction)will be used for maxillary en-masse retraction by extending the spring from the hook to the molar bands.

Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study.

干预措施: Friction mechanics (Device)

Frictionless mechanics

Active Comparator

Upper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires.

Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally.

Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. T-loops retraction arch ( frictionless mechanics of retraction)will be used for maxillary en-masse retraction. The wire will be cinched distal to the molar bands.

Re-activation of the retraction loops will be done in the follow up visits to maintain a constant force through the study

干预措施: Frictionless mechanics (Device)

结局指标

主要结局

Duration of retraction

时间窗: After complete retraction, average 9 months

months through clinical examination of the retracted anterior teeth

Rate of retraction

时间窗: Average 9 months, recorded from the begin of retraction till the complete retraction of anterior teeth

millimeters through dental models taken for each patient monthly at the follow up visit

Patient Satisfaction

时间窗: After complete retraction , average 9 months

Questionnaire will be filled by every patient at the end of the study regarding his experience and acceptance to the treatment, scale from 0 to 5 .

次要结局

  • Change in incisors inclination(After complete retraction, average 9 months)
  • Change in soft tissue profile(After complete retraction, average 9 months)
  • molar anchorage loss(After complete retraction, average 9 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sally Magdi Riad

Assistant lecturer- Orthodontic department

Cairo University

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