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临床试验/NCT06457672
NCT06457672尚未招募不适用

Assessment of The Accuracy of Complete Crown 3D Superimposition Technique Relative to The Gold Standard Technique for Digital Quantification of Volumetric Soft Tissue Changes in The Esthetic Zone

British University In Egypt2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
12
试验地点
2
主要终点
Superimposition accuracy

研究概览

简要总结

The aim of this study is to assess the precision of the complete crown technique employed for the superimposition of 3D models, specifically in the quantitative volumetric evaluation of gingival tissues. This technique was initially introduced in an in-vitro study by Dritsas et al. (2023) as a means to achieve an accurate, reproducible, and simple method for quantification of gingival recession.

详细描述

This study will involve the analysis of digital models in. ply format acquired through intraoral scanning of patients scheduled for esthetic crown lengthening,

A. Pre-analytical Phase:

In an interview, a full medical history is obtained. Clinical and radiographic examinations are completed before consent signing for study enrollment.

Full mouth supra and subgingival debridement will be performed for patients using an ultrasonic device with supragingival scaling inserts, followed by Universal or Gracey's curettes for thorough subgingival debridement. Patient preparation will be completed in a single visit. Comprehensive oral hygiene instructions will be provided to the patient, including instructions for brushing teeth twice daily using a soft toothbrush and employing a circular scrub technique.

Additionally, guidance will be given on interdental cleansing, using either waxed dental floss or a toothpick appropriate for the size of the interdental embrasure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years or older.
  • Patients requiring esthetic crown lengthening.
  • Full-mouth plaque and bleeding score not exceeding 20%.
  • Presence of at least 2.5 mm keratinized tissue width (Pontoriero & Carnevale, 2001).
  • Patients showing motivation to comply with post-operative care instructions and follow-up appointments.

排除标准

  • Systemic health conditions that contraindicate or affect healing of periodontal surgery.
  • Patients requiring prosthetic crowns or restorations in the esthetic zone.
  • Gummy smile with normal tooth proportions.
  • Patients treated with medications known to affect the gingiva (Phenytoin, Cyclosporine and Nifedipine).
  • Pregnant and nursing females.

结局指标

主要结局

Superimposition accuracy

时间窗: 6 months

Using Geomagic Software (RMS) in Millimeter(mm)

次要结局

  • Soft tissue volumetric Changes(6 months)
  • Intra-Inter Assessor reliability(6 months)
  • Gingival Margin level change(6 months)
  • Operator's satisfaction(6 months)

研究者

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

Ahmed Mohamed Hassan

assistant lecturer

British University In Egypt

研究点 (2)

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