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临床试验/NCT06795295
NCT06795295已完成不适用

Swallowing Dynamic of Two Implant Versus Single Implant Retained Mandibular Overdentures

Mansoura University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures

研究概览

简要总结

This Randomized clinical study was conducted to compare between two-implant versus single implant-retained mandibular overdenture regarding swallowing dynamic using The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST)

详细描述

There are lack of studies comparing single and two implant-retained mandibular overdentures regarding swallowing dynamic. This Randomized clinical study aimed to compare the effect of two treatment modalities of mandibular implant over denture on the swallowing dynamic.

8 completely edentulous patients were selected from the Out-Patient Clinic of Prosthodontics' Department, Faculty of Dentistry, Mansoura University seeking prosthetic rehabilitation. All patients were randomly distributed into two equal groups; Group I (Patients received two-implant mandibular overdenture with locator attachment) and Group II ( Patients received single implant mandibular overdenture with locator attachment) All subjects received a newly carefully constructed complete dentures and then the lower dentures were changed into mandibular implant retained overdentures using locator attachments by placing two implants on the mandibular canine regions for group I and single midline implant for group II.

Swallowing dynamic was evaluated after 3 months of complete denture insertion for both groups. After mandibular overdenture insertion swallowing dynamic was evaluated 2 weeks after insertion and three months after overdenture insertion for both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Free from any systemic disease.
  • •Free from any medical or surgical conditions that cause dysphagia (swallowing problems).
  • •A sufficient residual alveolar bone quantity (height and width). This was verified by a CT scan using cone-beam computed tomography for each patient.
  • •All patients had sufficient bone either D2 or D3 by measuring the Hounsfield unit on CBCT scan.
  • •Residual ridges are covered by firm healthy mucosa.
  • •Class I maxilla-mandibular relationship.
  • •sufficient inter-arch space and restorative space for locator retained mandibular overdenture.

排除标准

  • •Patient with absolute contraindications for implant placement such as active cancer, immunosuppression, bleeding issues, and metabolic diseases that directly affect the bone such as osteoporosis, and hyperparathyroidism.
  • •Patients with relative contraindication: history of para functional habits such as bruxism, clenching, and bad habits such as smoking and alcoholism, uncontrolled diabetic patients.
  • •Patients with local contraindications for implant placement due to localized bone defects.
  • •Non-cooperative patients who don't follow instructions during and after the operation.

研究组 & 干预措施

Group І 2- IMOVD

Active Comparator

Patients received two implant on the mandibular canine regions to retain mandibular overdenture with locator attachment

干预措施: Implant retained mandibular overdenture (Procedure)

Group ІІ 1-IMOVD

Active Comparator

Patients received single mandibular midline implant to retain mandibular overdenture with locator attachment

干预措施: Implant retained mandibular overdenture (Procedure)

结局指标

主要结局

Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures

时间窗: The evaluation of swallowing by TWST for (time per swallow, volume per swallow, and swallowing capcity) was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.

swallowing dynamic of both groups was evaluated by the Timed Water Swallow Test (TWST) to measure (time per swallow, volume per swallow,and swallowing capcity)

Swallowing Dynamic Of Two Implant Versus Single Implant Retained Mandibular Overdentures

时间窗: The evaluation of swallowing by TOMASS for(no swallows, no of chews,and total time)was done after 3 months (3M-CD) of CD insertion, three months (3M-OD) after overdenture insertion.

Evaluation of swallowing dynamic of both groups was done by The Test of Mastication and Swallowing Solids (TOMASS) to measure (number of swallows,number of chews,and total time)

次要结局

未报告次要终点

研究者

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

Mohamed Taha Abdo El_Baz

Clinical demonstrator, Prosthodontic Department, Faculty of dentistry, Mansoura University

Mansoura University

研究点 (1)

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