Accuracy of Intraorally Scanned Denture Impressions Compared to Conventional Border-Molded Impressions: An In Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Trueness of Digital Impressions: Mean root mean square Deviation (mm) between intraoral scanner (IOS) digital impressions and conventional impression scans-per arch
研究概览
简要总结
The goal of this clinical trial is to compare the accuracy of two denture impression techniques, digital intraoral scanning and conventional border-molded impressions, in adults who have lost all their teeth (fully edentulous patients).
The main questions it aims to answer are:
Is a digital intraoral scan as accurate as a conventional impression for capturing the shape of the mouth, including movable gum areas? Are repeated digital scans consistent (precise) when taken multiple times on the same patient? Researchers will compare digital impressions taken with an intraoral scanner to conventional impressions made with custom trays and border molding to see if digital scans can match the accuracy of the traditional "gold standard" method.
Participants will:
Attend Dubai Dental Hospital for two study visits. Have their mouth scanned three times using a digital intraoral scanner. Have a conventional impression taken using a custom tray and high-accuracy material after border molding.
Provide informed consent and allow their impression data to be analyzed for accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients attending DDH for complete dental prosthesis.
- •Fully edentulous patients
- •All alveolar ridge classifications of Cawood and Howell 1988 (Cawood and Howell, 1988)
- •Above 18 years old
- •Arabic and English-speaking patients
- •Good physical health (ASA class 1 or 2)
- •Willing to provide informed consent.
排除标准
- •Dentate patients
- •Implant-attachment-supported complete denture.
- •Patients un-willing to participate (non-consented patients)
- •Patients with severe gag reflex
- •Patients who are mentally unstable, drug users or alcoholics
研究组 & 干预措施
Edentulous patients
Arm Description:
Participants will first receive digital intraoral scanning of their fully edentulous upper and/or lower jaw using the TRIOS 5 intraoral scanner (3Shape). The scanning process follows a structured sequence to capture the entire arch, including the palate and ridge slopes. Each arch will be scanned three times during the same visit to assess precision (consistency of repeated scans). Then the same participants will also undergo a conventional impression procedure using a custom tray and border molding technique.
干预措施: Digital and conventional impressions (Procedure)
结局指标
主要结局
Trueness of Digital Impressions: Mean root mean square Deviation (mm) between intraoral scanner (IOS) digital impressions and conventional impression scans-per arch
时间窗: 1 week
Trueness will be checked by looking at the Root Mean Square (RMS) deviation (mm) after superimposing the IOS Standard Tessellation Language (STL) over the conventional impression scan STL (reference) using Geomagic Control X. The primary metric is the participant-level mean RMS over the full arch surface (edentulous maxilla and mandible analyzed separately). Lower RMS indicates greater trueness (higher accuracy). Region-specific RMS (static vs. dynamic tissues) will be recorded as prespecified analyses (see secondary outcomes). Alignment: Initial + best-fit alignment; conventional scan = reference file. Reporting (participant level): Mean RMS (mm) per arch. Reporting (study level): Mean \[Standard Deviation (SD)\], RMS per arch; 95% CI; distribution plots as applicable. Unit of Measure: millimeters (mm), RMS deviation Regions analyzed: Static (palatal rugae, ridge slopes, crest) and dynamic (labial, buccal, lingual sulci, hamular notch, posterior palatal seal).
Precision of Digital Impressions: Within-Subject Mean Pairwise RMS Deviation (mm) Across Three IOS Scans (Precision)-per Arch
时间窗: 1 week
Precision will be quantified by pairwise deviation analysis between three repeated IOS scans per arch taken on the same day. STL files will be aligned (Initial + Best-Fit ICP) in Geomagic Control X. For each arch, the following pairs will be analyzed: (Scan1-Scan2), (Scan1-Scan3), and (Scan2-Scan3). Each pair will be aligned in both directions (each file alternately as reference), and all RMS values will be averaged to yield the participant-level mean pairwise RMS (mm) for that arch. Lower RMS indicates greater precision (repeatability). Reporting (participant level): Mean of all pairwise RMS values per arch. Reporting (study level): Mean (SD) RMS per arch; 95% CI; distribution plots as applicable. Unit of Measure: millimeters (mm), RMS deviation
次要结局
- The difference (mm) in mean RMS trueness between the maxillary and mandibular arches is measured.(1 week)
- Difference (mm) in mean RMS trueness between static (attached) and dynamic (mobile) regions.(1 week)
研究者
Fatemeh Amir-Rad
Assistant Professor
Mohammed Bin Rashid University of Medicine and Health Sciences