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临床试验/NCT07256106
NCT07256106招募中不适用

Evaluation of The Occlusion and Dis-Occlusion Time in Mandibular Single Overdentures Supported by Conventional Versus Mini- Dental Implants; A Parallel Blinded Randomized Clinical Trial

Ain Shams University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年11月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
28
试验地点
2
主要终点
occlusion/dis occlusion time

研究概览

简要总结

The aim of the study will be comparing between the occlusion and disocclusion time in mandibular single overdenture supported with immediately loaded two conventional implants versus immediately loaded four mini-implants.

Research question Is there a difference in occlusion and disocclusion time between two mandibular single dentures, one supported by immediately loaded two conventional implants and the second one supported by immediately loaded four mini-implants? Primary outcome: occlusion and disocclusion time Secondary outcome: Kapur index The null hypothesis is that there is no difference between both treatment modalities on occlusion and disocclusion time.

详细描述

Twenty eight patients will be selected to share in this study from the outpatient clinic of Prosthodontics Department, Faculty of Dentistry, Ain-Shams University.

Sample size was calculated according to these values producing a minimal sample size of Twenty eight patients being enough to find such a difference. The size was determined in the light of the study " Computerized occlusal analysis of mini-dental implant-retained mandibular overdentures: A 1-year prospective clinical study " 34 with alpha error probability of 0.05, 1-beta error probability , power of 0.8 and drop out ratio 5%.

The inclusion criteria will be patients with completely edentulous lower ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration, exhibiting enough inter-arch space to allow for prosthetic rehabilitation with lower implant-retained overdentures and have good oral hygiene and motivation. The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.

The patients will make a complete oral and radiographic examination before inclusion in this study.

For allocation concealment, one of the postgraduate students who will be the only one to know the key so that the authors and the patients won't know in which group the patient will be. Afterwards, the authors will be informed by the randomization to be tabulated.

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)

盲法说明

Masking of the outcome assessor the one responsible for measuring the occlusion/dis occlusion time

入排标准

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

入选标准

  • •patients with completely edentulous mandibular ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration,
  • •enough inter-arch space to allow for prosthetic rehabilitation with lower implant-retained overdentures
  • •good oral hygiene and motivation.

排除标准

  • •The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.

研究组 & 干预措施

conventional implant supported mandibular overdenture

Active Comparator

Group CI patients will be rehabilitated with mandibular overdentures retained by two immediately loaded conventional implants inserted in the inter-foraminal region.

干预措施: conventional dental implant (Procedure)

mini-implant supported mandibular overdenture

Experimental

Group MI patients will be rehabilitated with single mandibular overdentures retained by four immediately loaded mini implants inserted in the inter-foraminal region.

干预措施: mini dental implant (Procedure)

结局指标

主要结局

occlusion/dis occlusion time

时间窗: 1 year

Occlusal parameters: occlusion time (OT) and disocclusion time (DT) will be recorded for each patient. The patient will be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start right eccentric movement until disoccluding their teeth. This will be repeated 4 times for the right excursion (DT-right) and 4 times for the left excursion (DT-left). OT, DT-right, and DT-left were then calculated by taking the averages of the recordings.

occlusion/dis occlusion time

时间窗: 1 year

Occlusal parameters: occlusion time (OT) and disocclusion time (DT) will be recorded for each patient. The patient will be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start right eccentric movement until disoccluding their teeth. This will be repeated 4 times for the right excursion (DT-right) and 4 times for the left excursion (DT-left). OT, DT-right, and DT-left were then calculated by taking the averages of the recordings.

次要结局

  • denture stability(1 year)
  • denture stability(1 year)

研究者

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

Ahmed Mostafa Abdelfatah

Associate professor , faculty of dentistry

Ain Shams University

研究点 (2)

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