跳至主要内容
临床试验/NCT07618013
NCT07618013尚未招募不适用

Clinical Effectiveness of Using Surface Sealants on Cervical Resin Composite Restorations in Comparison With Non-sealed Restorations: A 2-year Randomized Clinical Trial

Cairo University0 个研究点目标入组 25 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25

研究概览

简要总结

After finishing and polishing are completed, the tooth surface may exhibit microcracks and micro-irregularities that create a roughened surface, which may lead to plaque retention, gingival inflammation, and discoloration. The surface-penetrating sealant was introduced to fill micro-irregularities by capillary action, providing a uniform, regular surface and enhancing the surface smoothness. The application of unfilled low-viscosity surface sealants aims to enhance the luster, smoothness, and color stability of esthetic restorations and decrease stain absorption. They have low viscosity that enables them to easily spread and penetrate over these finished and polished surfaces, which may affect the life of the restoration positively. Additionally, it decreases surface porosity and creates a surface that is more thoroughly cured, improving the composite's stain resistance.

This prospective, parallel-group, randomized clinical study aims to compare the clinical effectiveness of using surface sealants on cervical resin composite restorations versus non-sealed restorations. Restorations will be assessed at baseline, 6, 12, 18, and 24 months using modified USPHS criteria. The primary outcome will be assessing marginal discoloration, and the secondary outcomes will be assessing color match, secondary caries, postoperative sensitivity, surface texture, and marginal adaptation. Color stability will be assessed by VITA Easyshade®.

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)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participant Inclusion Criteria:
  • Adult patients aged 18-55 years.
  • Patients with good oral hygiene (mild to moderate plaque accumulation).
  • Patients with asymptomatic class V cavities in permanent teeth.
  • Teeth inclusion criteria:
  • Vital posterior teeth with class V carious cavities.
  • Moderate cavities (ICDAS 3 & 4).
  • Free from signs and symptoms of irreversible pulpitis and pulpal necrosis.
  • Teeth with no or grade 1 mobility.
  • Participant

排除标准

  • Patients who are unable to return for recall appointments.
  • Patients with poor oral hygiene.
  • Presence of abnormal oral, medical, or mental condition
  • Presence of any parafunctional habits.
  • Patients with TMJ problems.
  • Teeth Exclusion Criteria:
  • Periodontal disease that may affect the prognosis of the restoration or the tooth itself.
  • Fractured or visibly cracked teeth.
  • Presence of any developmental or formative defects.

研究者

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

Nanees Ayman Hassan Aly

Lecturer Assistant, Conservative Dentistry Department, Faculty of Dentistry

Cairo University

相似试验