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临床试验/NCT04384237
NCT04384237Unknown不适用

Effect of Er,Cr: YSGG Laser - Aided Circumferential Supracrestal Fiberotomy in the Prevention of the Lower Incisors Rotational Relapse

Fundación Universitaria CIEO2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Quantity of anterior mandibular rotation relapse

研究概览

简要总结

To establish the effect of erbium, chromium,yttrium,scandium,gallium and garnet (Er,Cr: YSGG) laser-aided circumferential supracrestal fiberotomy compared to a conventional circumferential supracrestal fiberotomy group, after leveling and alignment during the first month after arch wire removal on the prevention of rotational relapse in lower incisors.

Methods: Randomized clinical trial in 60 orthodontic patients with two to four lower incisors rotation between 30º-50º degrees before treatment.They are going to be assigned in two intervention groups, each group with 30 patients. One group are going to be treated with Er;Cr: YSGG laser -aided CSF and the other group with conventional circumferential supracrestal fiberotomy. After leveling and alignment each procedure will be performed and after one month healing the arch wire will be removed for a month and lower incisor relapse will be measured through cast models in a software. Periodontal parameters will be registered before and after procedures.The outcomes are going to be determined and compared between groups with corresponding statistical test and results will be analyzed

详细描述

(Population, intervention, comparison, outcomes )PICO QUESTION Is there any difference in the amount of rotational relapse of the anterior lower teeth after leveling and alignment between Er;Cr:YSGG laser-aided circumferential supracrestal fiberotomy compared with conventional circumferential supracrestal fiberotomy after the removal of the arch wire one month once healed?

Population: Orthodontic patients with lower incisors rotation between 30º-50º degrees

Intervention:Er:Cr;YSGG Laser-aided CSF (Waterlase, Biolase, Irvine,California, USA) Comparison: Conventional CSF

Outcomes Primary Outcome: rotation relapse degree after one month removed teeth from the arch wire Secondary Outcome: probing depth and clinical crown height (gingival margin position)baseline, after leveling and alignment stage one month removed lower incisors from the arch wire.

AIMS

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Single (outcomes Assessor) An external clinic is going to do the measures

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

  • Non gingivitis or untreated caries
  • lower teeth with 30º-50º rotation degree
  • 2 mm keratinized tissue band
  • at least 2 rotated mandibular teeth

排除标准

  • Root canal treatment
  • Marginal Recessions
  • Interproximal bone loss in Rx
  • Thin gingival biotype (periodontal probe translucency
  • Reduced periodontium
  • systemic diseases or medications that alters bone metabolism.
  • Pregnancy

结局指标

主要结局

Quantity of anterior mandibular rotation relapse

时间窗: one month after arch wire removal

Er,Cr.YSGG laser-aided fiberotomy and Conventional CSF. Alginate impressions and cast models at the beginning of the study.Herb curve to measure the initial rotation grade. Impressions and measurements after the leveling and alignment phase, fiberotomy procedure, retention for one healing month. 30 days later of the removal of the arch wire, alginate impressions and measures will be taken by previously-calibrated operators

次要结局

  • Changes in probing depth(baseline and two months after fiberotomy)
  • Changes in clinical crown height(baseline and two months after fiberotomy)
  • Pain levels(after procedures, 24, 48 and 72 hours)

研究者

发起方
Fundación Universitaria CIEO
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Leal

Docent

Fundación Universitaria CIEO

研究点 (2)

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