A Comparative Analysis of Digital and Conventional Techniques for Prosthetic Rehabilitation of Edentulous Patients in Dubai.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 主要终点
- Occlusal Force Distribution and Contact Accuracy
研究概览
简要总结
15 Patients requiring complete dentures will be recruited from Dubai Health. Each patient will receive two sets of dentures with a washout period between sets. Patients will remain blinded to the fabrication method used for each set.
- Group 1: Participants will first receive conventionally fabricated dentures for both the upper and lower jaws. This set will be made using traditional techniques, including impressions, a custom tray, jaw relation recording, try-in, and final fitting. After the washout period, they will receive a second set created with the 3D-printed technique.
- Group 2: Participants in this group will initially receive 3D-printed complete dentures through a digital workflow, which involves intraoral scanning, STL file export, digital design, design review with the patient, 3D printing, and final fitting. Following the washout period, they will then receive a conventionally fabricated set.
详细描述
To ensure randomization and reduce order effects, participants will be randomly assigned to Group 1 or Group 2 using a stratified randomization approach in Microsoft Excel. A computer-generated random number will determine group allocation, ensuring that both groups have a balanced distribution based on age, gender, and oral health status. The randomization process will assign participants to either receive conventional dentures first (Group 1) or digital dentures first (Group 2), with a washout period between treatments. By randomizing the sequence of denture delivery, this method will control for potential biases in patient-reported outcomes (OHIP-14, DSQ) and clinical assessments, ensuring that the order of treatment does not influence the study results.
The following outcomes will be analysed:
- Quality of life (Qol) through Oral Health Impact Profile (OHIP-14)
- Patient reported outcomes (PROMS)
- Occlusal analysis - through conventional and digital analysis devices
- Costs
- Number of appointments
- Time AccuracyOutcome Measures The primary outcome of this study is the assessment of occlusal analysis using conventional and digital techniques.
The secondary outcomes include:
- Oral health-related quality of life (OHRQoL), measured using the validated Oral Health Impact Profile (OHIP-14).
- Patient-reported outcomes (PROMs), assessed through the Denture Satisfaction Questionnaire (DSQ), evaluating comfort, aesthetics, speech, and functional satisfaction.
- Number of appointments, recorded as the total number of visits required for fabrication and delivery of both conventional and digital dentures.
- Time efficiency, measured by recording the clinical duration required for key stages such as impressions and final insertions.
- Denture accuracy, assessed through 3D scanning and superimposition analysis using Geomagic Control X software, quantifying deviations between the designed and fabricated dentures. Clinical evaluation of fit, retention, and stability will also be conducted using a standardized grading scale.
- Cost-effectiveness, evaluated using a model adapted from McKenna et al. (2014), where the total cost per patient is divided by the OHIP-14 improvement score to yield a cost per one-point improvement in quality of life. This is benchmarked against the minimally important difference (MID), defined as a 5-point improvement:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults above the age of eighteen years seeking replacement of missing teeth
- •Edentulous patients 6 months after extraction of any teeth
- •Males and Females
排除标准
- •Temporomandibular Joint Disorders(TMD)
- •Limited mouth opening
- •History of Head and neck oncology
- •Conditions- such as Psychiatric conditions and Neurological conditions-, such as Parkinson's disease and Alzheimer's
结局指标
主要结局
Occlusal Force Distribution and Contact Accuracy
时间窗: 12 months
Quantitative assessment of occlusal contact number, area, timing, and force distribution in digital versus conventional complete dentures, measured using T-Scan and ModJaw systems, and validated against articulating paper marks.
次要结局
- Oral Health-Related Quality of Life (OHRQoL)(12 months)
研究者
May Al Janahi
Prosthodontist
Mohammed Bin Rashid University of Medicine and Health Sciences