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临床试验/NCT04436094
NCT04436094Unknown不适用

Soft Tissue Outcomes Of Badly Broken-Down Teeth Treated With Orthodontic Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 26 人开始时间: 2020年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
26
主要终点
Soft tissue outcome

研究概览

简要总结

Many patients suffer from tooth substance loss as a result of fracture or decay of teeth situated in the esthetic zone. This might commonly occur with car accidents, sport injuries, falls or even fistfights.

For those patients, most of the crown is lost and only the root remains, so there is no enough ferrule in order to restore the tooth with a crown.

The most common treatment for those patients is immediate single-tooth implant. However, some problems may arise such as: high treatment expenses, the need for bone augmentation, the refill of the papilla to its normal position may be questionable in some implant cases, young growing patients, apprehensive patients, dental facilities and rural areas lacking cone beam computed tomography (CBCT) machines.

Accordingly, orthodontic extrusion may be an alternative attempt to preserve the tooth by traction of the remaining root to create a sufficient ferrule effect to restore the tooth.

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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients).
  • Single rooted teeth with adjacent intact or restored neighboring teeth, more than one tooth may be included in the same arch.
  • More than 1:1 crown root ratio, so that the C/R is 1:1 after extrusion and restoration.
  • Presence of intact adjacent teeth.

排除标准

  • Badly broken-down teeth with active signs of infection.
  • Teeth with vertical root fracture.
  • Teeth with severely tapered roots..
  • Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
  • Potentially uncooperative patients who are not willing to go through the proposed interventions (patients who will refuse to undergo orthodontic treatment).
  • Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems, emotional instability, and unrealistic esthetic demands.
  • History of radiation therapy to the head and neck, or bone augmentation to implant site.
  • Labial cortical bone fenestration diagnosed from CBCT.

结局指标

主要结局

Soft tissue outcome

时间窗: 12 months

Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value

次要结局

  • Survival(12 months)

研究者

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

Moustafa Osama Shehata

Principal Investigator

Cairo University

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