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临床试验/NCT05198687
NCT05198687Unknown不适用

Comparison Between Three Different Treatment Modalities for Atrophied Distal Extension Maxillary Ridges Clinical and Radiographic Study

Mansoura University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Plaque index

研究概览

简要总结

This study will compare clinical and radiographic outcomes of three different treatment modalities for atrophied distal extension maxillary ridges these modalities include

  1. Implant retained distal extension RPD
  2. Sinus lift and long implant and screw-retained prosthesis
  3. Short implant and screw-retained prosthesis

详细描述

Patient selection:

For this study, 60 patients were selected from the clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University.

Inclusion criteria:

The patients will be selected according to the following:

  • They have distal extension maxillary ridge with sinus pneumatization and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, have no previous denture experience. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
  • Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
  • Patients are less satisfied with conventional RPD.
  • Absence of maxillary sinus diseases. Exclusion criteria

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
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • The patients will be selected according to the following:
  • They have distal extension maxillary ridge with sinus pneumatization and remaining alveolar bone height 6- 8mm as verified by preoperative CBCT, have no previous denture experience. They are healthy, free from any systemic diseases relating to the bone resorption (diabetes - hyperparathyroidism). This can be achieved through medical history and clinical examination by a physician and laboratory investigations.
  • Posterior maxillary alveolar ridge deficient in height, width and covered with healthy firm mucosa.
  • Patients are less satisfied with conventional RPD.
  • Absence of maxillary sinus diseases.

排除标准

  • Acute or chronic sinus pathology
  • History of a sinus augmentation in the past in the relevant sinus
  • Poor dental hygiene. Smoker.
  • Compromised general health (uncontrolled diabetes, bleeding disorder

结局指标

主要结局

Plaque index

时间窗: one year

measuring plaque accumulation around implants using scores

Gingival index

时间窗: one year

measuring gingival inflammation around implants using scores

Marginal bone loss

时间窗: one year

measuring crestal bone loss around implants in mm

Probing depth

时间窗: one year

measuring peri-implant probing depth in mm

implant stability

时间窗: one year

measuring the mobility of the implants using resonance frequency analysis Implant stability quotient)

Patient satisfaction using VAS questionnaire (visual analogue scale)

时间窗: one year

Regarding VAS, participants were asked to score their answer according to the amount of satisfaction on a 100mm line (Score zero = no satisfaction at all and score 100 = complete satisfaction). The questions cover several items related to prosthesis such as: retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus and appearance.

次要结局

  • Muscle activity(one year)
  • Prosthetic Aspects(one year)
  • maximum bite force(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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