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临床试验/NCT07228988
NCT07228988进行中(未招募)不适用

Patient-Related Outcomes of Digital and Conventional Removable Partial Dentures..A Crossover Randomised Clinical Trial

King Abdulaziz University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年4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
进行中(未招募)
入组人数
36
试验地点
2
主要终点
Patient satisfaction using VAG

研究概览

简要总结

Study type: cross over within subject clinical trial Primary aim: To compare patient satisfaction among three different RPDs: conventional cast Co-Cr, 3D-printed Co-Cr, and PEEK RPDs.

Secondary aim: To evaluate the impact of these RPDs on oral health-related quality of life and patient preference among these RPDs

详细描述

A within-subject randomized crossover clinical was conducted at the Faculty of Dentistry, King Abdulaziz University after obtaining an ethical approvalfrom the Faculty Ethical Committee. All patients have signed a consent before being enrolled in the study.

Each participant received three RPDs using three manufacturing techniques (conventional cast Co-Cr, 3D-printed Co-Cr, and milled PEEK) fabricated to the same RPD design specifications. Each RPD worn for 30 days with a one-week washout period between the trial phases.

Participants were selected from partially edentulous patients fulfilling mandibular Kennedy Class I with the first or second premolars as the last abutment teeth bilaterally . Inclusion criteria include good oral hygiene, healthy mucosa, and absence of systemic diseases affecting oral tissues. Exclusion criteria include allergy to materials, poor compliance, or history of temporomandibular disorders.

Sample size estimation is based on detecting a moderate effect size (f = 0.25) with 80% power and α = 0.05, requiring at least 30 participants. To account for possible dropouts, a total of 36 patients was recruited.

Patient satisfaction was assessed using the Visual Analogue Grade (VAG) scale (0-100 mm). The VAG evaluates satisfaction domains such as comfort, esthetics, speech, and mastication, while OHIP-14 measures the impact of oral health on quality of life through 14 questions covering 7 domains. At the end of all the treatment phases participants determined the most preferred denture by answering single choice question of the best overall denture among the three types.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •- Partially edentulous patients with mandibular Kennedy class I, last abutment is the first or second premolars, maxillary arch is dentate or restored, good oral hygiene

排除标准

  • •Any systemic diseases that affect oral health, periodontal disease, improper patient compliance, TMD

研究组 & 干预措施

Conventional cast Co-Cr removable partial denture

Active Comparator

This type of RPD is constructed from Cobalt Chromium metal framework using the lost wax technique conventional casting of a wax pattern made on an investment cast.. Each participant used the conventional denture for 30 days then they received the VAS and OHIP-14 questionnaire about their denture experience..Then wait one week without any dentures until they received the second denture type

干预措施: Conventional cast Cr-Co RPDs (Device)

3D Printed Cr-Co removable partial denture

Experimental

This is a digital RPD made from Cobalt Chromium metal which is printed by a 3D printer using selective laser melting technique..Each participant used the 3D printed denture for 30 days then they received the VAS and OHIP-14 questionnaire about their denture experience..Then wait one week without any dentures until they received the next denture type

干预措施: 3D Printed Cr-Co RPDS (Device)

Milled PEEK removable partial dentures

Experimental

This is a digital type of RPD made by milling polyetheretherktone discs using a milling machine..Each participant used the PEEK denture for 30 days then they received the VAS and OHIP-14 questionnaire about their denture experience..Then wait one week without any dentures until they received the other denture type

干预措施: Milled PEEK RPDs (Device)

结局指标

主要结局

Patient satisfaction using VAG

时间窗: Delivery of the first denture type 1st questionnaire 30 days after receiving the first denture 7 days wash out Delivery of the second denture type 2nd questionnaire 30 days after using the denture 7 days wash out Final questionnaire after 30 days

Visual Analogue Grade 100 mm scale is used to measure patient satisfaction and comfort as zero indicates the worst and 100 indicates the best response

次要结局

  • Oral Health related Quality of Life OHRQoL(Delivery of the first denture type 1st questionnaire 30 days after receiving the first denture 7 days wash out Delivery of the second denture type 2nd questionnaire 30 days after using the denture 7 days wash out Final questionnaire after 30 days)
  • Patient preference(After all the three dentures treatment phase 30 days after the delivery of the last denture according to sequence randomisation Study time line was 6 months from recruitment to final questionnaire)

研究者

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

Enas Mesallum

Assistant Professor

King Abdulaziz University

研究点 (2)

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