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临床试验/NCT06567262
NCT06567262尚未招募不适用

Oral Health Related Quality of Life and Cost Effectiveness in CAD/CAM and Conventional Metallic Partial Denture Frameworks in Mandibular Kennedy Class III Cases: A Randomised Cross-over Trial

Cairo University0 个研究点目标入组 19 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
19
主要终点
Oral health related quality of life

研究概览

简要总结

Patients will be randomised to receive CAD/CAM metallic removable partial denture (RPD) followed by Conventional metallic RPD (Group A), or the opposite sequence (Group B), with a 3-month wear duration for each denture and washout period for one week. Patients will be recalled at base line and 3 months following prosthetic insertion to evaluate Oral health related quality of life. It is hypothesized that removable partial dentures with CAD/CAM metallic RPD frameworks would improve Oral health related quality of life than those with Conventional metallic RPD frameworks.

详细描述

Eligible patient will be selected from outpatient clinic in removable prosthodontics department clinic. Patients will be informed of the nature of the research work and informed consent will be obtained from each of them. Only motivated patients who shows cooperation will participate in the study. Patients will be randomised to receive CAD/CAM metallic RPD followed by Conventional metallic RPD (Group A), or the opposite sequence (Group B), with a 3-month wear duration for each denture and washout period for one week. Patients will be recalled at base line and 3 months following prosthetic insertion to evaluate Oral health related quality of life and cost effectiveness.

Patients will be subjected to:

  • Comprehensive clinical examination and understanding of patient's chief complaints and their expectations from the prosthesis.
  • Digital periapical radiographs with paralleling technique will be taken for the abutment teeth as base line for bone height before prosthesis construction.

CAD/CAM metallic RPD:

  1. Make digital scans using an intraoral scanning device. Scan the maxillary (antagonistic scan) and mandibular (pre-preparation scan) arches, as well as an initial digital record of the inter-occlusal relation (occlusal scan).
  2. Analyse the digital cast using CAD software. Primary electronic surveying will be carried out to ensure if the tooth preparations will be needed.
  3. Make a definitive intraoral scan only of the prepared teeth and record the maxillary-mandibular relationship.
  4. The virtual cast is digitally surveyed and the design of the framework is done using computer software. The wax pattern 3D framework information will be converted into a standard tessellation language (STL) file and transfer to a rapid prototyping (RP) system to be printed and finally cast using the conventional technique to produce RPD framework.
  5. The overall treatments costs, including the fees from the dental laboratory, will be calculated and compared with the costs of a conventionally fabricated RPD.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients with unilateral bounded saddles in the mandible (Kennedy class III).
  • Opposing dentition is fully intact or restored.
  • Sufficient inter-arch space.
  • Angle's class I maxilla-mandibular relationship.

排除标准

  • Periodontal affection of the abutment teeth.
  • Skeletal mal-relation.
  • Unmotivated patients to maintain adequate oral hygiene to follow up.
  • Patients with neuromuscular and Psychiatric disorders.
  • Systematic disease affecting bone and periodontal health.
  • Insufficient inter-arch space.
  • Patients with physical reasons that could affect follow up.

结局指标

主要结局

Oral health related quality of life

时间窗: 3 months

Oral health related quality of life will be measured by a valid and reliable questionnaire which is Oral health impact profile questionnaire (OHIP) before RPD insertion then after RPD insertion with one and 3 months for both groups. It consists of 5 questions representing the four suggested dimensions: Oral Function, Orofacial Pain, Orofacial Appearance and Psychosocial Impact. Questions were made on a 5-point Likert scale (0 = never; 1 = hardly ever; 2 = occasionally; 3 = fairly often; and 4 = very often).

次要结局

  • Cost effectiveness(3 months)

研究者

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

Tarek Salah Hashim Ali

assistant lecturer

Cairo University

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