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临床试验/NCT06732115
NCT06732115尚未招募不适用

Esthetic Performance and Surface Roughness of Class IV Nanohybrid Composite Restorations Following One-step Versus Multistep Polishing Protocol: a Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Surface Luster (success rate)

研究概览

简要总结

This study aims to evaluate the effectiveness of various finishing and polishing techniques for composite resins used in dental restorations, with a focus on minimizing discoloration and surface roughness over time. Discoloration due to plaque accumulation and surface staining can lead to esthetic concerns, resulting in premature restoration replacement and increased costs. Prior research highlights that esthetic failures, such as color alterations and surface staining, are key reasons for the failure of anterior restorations. Given the contradictory findings in previous studies on finishing and polishing methods, this research seeks to determine whether one-step polishing system will have the same effect as the multistep system in terms of esthetic performance and surface roughness of nanohybrid resin composite class IV restorations. The main operator will compare between OneGloss (Shofu) the intervention and Super-Snap X-treme (Shofu) the comparator. Patients will be evaluated immediately following polishing then after 3 months, 6 months, and 12 months.

研究设计

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

盲法说明

statistician

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Patient related criteria:
  • •Patients with good general health.
  • •Patients who agreed to the consent and committed to follow-up period
  • •No specific age range.
  • •Both genders.
  • •Low and moderate caries risk patients
  • •Normal occlusion
  • •Tooth related criteria
  • •Fully erupted permanent anterior teeth with class IV.
  • •Active caries, fractures, or defective Restorations in anterior teeth.

排除标准

  • •Patient related criteria
  • •Patient with bad oral hygiene.
  • •Patients with tetracycline or fluorosis staining.
  • •Patients who could/would not participate in all times of follow-up.
  • •Patients participating in more than 1 dental study.
  • •Patient received fluoride varnish, or during orthodontic treatment.
  • •Patients with tendency to do bleaching during the study.
  • •Heavy Smokers
  • •Patients who are alcoholic and addicted Tooth related criteria
  • •Untreated periodontal disease was not allowed
  • •Fully erupted anterior teeth with no defects

研究组 & 干预措施

Intervention

Experimental

One-step polishing system with nanohybrid resin composite restorations

干预措施: One-step polishing system with nanohybrid resin composite restorations. (Procedure)

Compartor

Active Comparator

Multistep system polishing system with nanohybrid resin composite restorations.

干预措施: Multistep system polishing system Super-Snap X-treme (Shofu) with nanohybrid resin composite restorations. (Procedure)

结局指标

主要结局

Surface Luster (success rate)

时间窗: 24hours, 3 months, 6months and 12 months

Scoring system (ordinal) 5: Luster comparable to enamel 4: Slightly dull, not noticeable from speaking distance, some isolated pores 3: Dull surface but acceptable if covered with film of saliva, multiple pores on more that one-third of the surface 2: Rough surface, cannot be masked by saliva film, simple polishing not sufficient 1: Very rough, unacceptable plaque-retentive surface

次要结局

  • Surface Staining(24hours, 3 months, 6months and 12 months)
  • Marginal Staining(24hours, 3 months, 6months and 12 months)
  • Color Match(24hours, 3 months, 6months and 12 months)
  • Surface Roughness(24hours, 3 months, 6months and 12 months)

研究者

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

Noreen Amr Labib

Master degree student in operative department, faculty of dentistry, Cairo University

Cairo University

研究点 (1)

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