跳至主要内容
临床试验/NCT02952274
NCT02952274Unknown不适用

Comparison Between Ball and Locator Attachments in Patients Receiving Complete Mandibular Overdenture Retained by Single Midline Implant

Cairo University0 个研究点目标入组 22 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
22
主要终点
OHRQoL (oral health related quality of life)

研究概览

简要总结

The aim of this study is to compare the ball attachment to the locator attachment regarding the OHRQoL (oral health related quality of life) for completely edentulous patients retaining a mandibular overdenture with a midline placed implant

详细描述

The selected patients will be informed of the nature of the research work and informed consent will be obtained for each one of them. Only motivated patients who showed co-operation will participate in the study. Patients will be randomly divided into 2 groups.

Conventional upper and lower complete dentures will be constructed before installing the implant where the lower denture will be duplicated into a radiographic stent. CBCT (cone beam computerized tomography) with lower radiographic stent in place stabilized with the upper denture using a rubber base index, will be taken to know the available bone height &width to determine the optimum implant size.

Patients will receive single implant in symphyseal region of mandible. The surgical procedure is carried out under local anaesthesia, following premedication with 2 g amoxicillin (or 600mg of clindamycin) and 1 g paracetamol. After two rinses with 0.2% chlorhexidine gluconate, each lasting 1 min, the labial and lingual mucosa of the anterior mandible is locally infiltrated with 2.2 ml of mepivacaine 2% with 1 : 100,000 adrenalin. The surgical guide made from the duplicated mandibular complete denture is used to mark the implant site.

A crestal incision will be performed and a full-thickness mucoperiosteal flap is raised to expose the anterior mandible. Deep dissection of this flap lingually exposes the cortical plate of the mandible and any lingual concavities. Sequential drilling & implant placement will be the next step. The implant position is adjusted to the midline of the mandible and optimum labiolingual positioning and bone levelling is performed as necessary.

A healing abutment is selected to be 2mm above the mucosa. The mucosa is adjusted and sutured with interrupted sutures (3-0 silk). Postoperatively, the patient should rinse with 0.2% chlorhexidine gluconate mouthwash for 2 weeks. Immediately following implant surgery, generous relief of the existing mandibular complete denture is carried out and a tissue conditioner is applied to the undersurface of the denture. The patient leaves after the surgical operation wearing both the complete maxillary denture opposed by the tissue-conditioned mandibular complete denture. A period of 8 weeks will be allowed for healing and osseointegration.

研究设计

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

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Completely edentulous patient
  • Patients having enough bone for an implant length of at least 10 mm
  • No apparent bony mal-relation.
  • No intraoral soft and hard tissue pathology
  • No uncontrolled systematic diseases such as hypertension, diabetes and immunodeficiency.

排除标准

  • Drug or alcohol abuse,
  • A health condition precluding surgery,
  • Physical reasons that could affect follow-up,
  • Psychiatric problems,
  • Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site.

结局指标

主要结局

OHRQoL (oral health related quality of life)

时间窗: 6 months

次要结局

  • Peri-implant Probing Depth(6 months)
  • Peri-implant Plaque index(6 months)

研究者

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

Ahmed Mohamed Hussein El-Baz

Dr.

Cairo University

相似试验