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临床试验/NCT07707323
NCT07707323招募中不适用

In Vivo Diagnostic Accuracy of Innovative Photo-Analysis Software and Digital Spectrophotometer Compared With Visual Technique in Resin Composite Shade Matching

Misr University for Science and Technology1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
52
试验地点
1
主要终点
Accuracy of computer software, digital Spectrophotometer and visual method in shade matching using resin composite tabs.

研究概览

简要总结

This study aims to assess the agreement between new computer software using dental photographs, digital spectrophotometer and the visual technique, in achieving accurate resin composite shade matching.

详细描述

  • Custom composite resin shade tabs are fabricated and catalogued to serve as reference standards during shade matching.

  • Teeth are professionally cleaned on dental chair using a nylon prophylaxis brush with polishing paste to ensure complete removal of extrinsic stains and to reveal the native tooth color.

  • Participants will be seated on an adjustable chair in an upright posture, with the head oriented perpendicular to the floor and be stabilized by a headrest. The chair will be positioned against a matte white wall adjacent to a clear window to standardize a neutral background and exploit consistent daylight illumination.

  • Patients will be instructed to maintain an upright head posture with the interpupillary line parallel to the floor. All measurements will be performed under daylight, while extraneous light sources and environmental interferences to be minimized.

  • Computer-Assisted Software A standardized Computer-assisted photographic shade-matching workflow will be employed using a novel photo-analysis software that first receives the photos and balances each photo to suppress unrealistic colors using a standard gray reference card (WhiBal; Michael Tapes Design), with nominal colorimetric targets of L* =75, a* = 0, b* = 0, will be included in every photograph within the plane of the teeth.

The Photo is firstly captured with a Nikon D3400 DSLR crop-frame camera (Nikon Corp) mounted on a stable tripod to avoid movements during capturing the photo and set the proper angulation and parallelism. All camera parameters will be standardized.

The program establishes a pixel-to-metric conversion scale (cm) from known distances and overlays orthogonal reference axes to fix landmark orientation and reproducible measurement geometry. Using these guides, tooth height and width are annotated, and the region of interest is consistently defined at the central area of the middle third of the labial crown of either the tooth or shade tabs.

Candidate shades are then quantitatively compared to the region of interest by computing CIEDE2000 color-difference values (ΔE₀₀), which incorporate corrections for lightness, chroma, and hue; the final selected shade is the one yielding the smallest ΔE₀₀.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-45 years.
  • Sex: Male or female.
  • General: Cooperative individuals who agree to participate and comply with study visits (written informed consent to be obtained as applicable).
  • Dentition: Presence of sound maxillary incisors that will meet the tooth-level criteria.

排除标准

  • Poor oral hygiene.
  • Severe systemic/medical complications that may contraindicate elective dental care.
  • Pregnancy.
  • Heavy smokers.
  • Xerostomia.
  • Temporomandibular joint disorders.

结局指标

主要结局

Accuracy of computer software, digital Spectrophotometer and visual method in shade matching using resin composite tabs.

时间窗: Baseline

• The outcome evaluates agreement of the computer software in comparison to spectrophotometer and traditional visual method.

次要结局

未报告次要终点

研究者

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

Ahmed Mohamed Saleh Ali Farrag

resident doctor

Misr University for Science and Technology

研究点 (1)

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