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临床试验/NCT06635382
NCT06635382尚未招募不适用

Clinical Evaluation of Dimethyl Sulfoxide Wet Bonding Technique: A Randomized Controlled Trial

Manipal University College Malaysia0 个研究点目标入组 68 人开始时间: 2024年10月20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
68
主要终点
Fracture of material

研究概览

简要总结

Dimethyl sulfoxide (DMSO) wet bonding has shown promising results in several in vitro studies. However, there are a lack of clinical trials which prove the advantages of this technique. The aim of the study is to clinically assess the effect of DMSO wet bonding on composite restoration in non carious cervical lesions.

研究设计

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

入排标准

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

入选标准

  • Two similar non carious cervical lesions (NCCLs) on the facial/labial surfaces of premolars.
  • NCCLs of score 1-3 on the Smith and Knight tooth wear index.
  • Favorable occlusion and teeth are in normal contact.

排除标准

  • NCCLs on the lingual surface.
  • Medically compromised individuals.
  • Periodontally compromised teeth.
  • Bruxism and visible wear facets in the posterior dentition.
  • Fractured or visibly cracked premolars and canines.
  • Known allergies to resin-based restorative materials.
  • Presently undergoing orthodontic treatment.
  • Abutment teeth for fixed or removable prostheses.

结局指标

主要结局

Fracture of material

时间窗: From treatment to 3-6 months follow up

Different fracture patterns and retention failures may occur in relation to the type of restoration: cracks, chipping/ delamination, bulk fractures, or incomplete and complete loss of retention. Assessed by Visual examination and short air drying. Criteria set from Clinically excellent/very good(sufficient) (Score 1) to Clinically poor (entirely insufficient)(Score 5)

Marginal adaptation

时间窗: From treatment to 3-6 months follow up

There are different interfaces between the dental hard tissue, restorative material, and adhesive and/or luting resin/cement layer. Each interface can degrade and potentially alter marginal adaptation. In clinical practice, it is impossible to distinguish failures between the different interfaces. Therefore, only the marginal adaptation as such can be assessed by visual examination and short air drying. Scores given depending upon the quality of restoration from Clinically excellent/very good (sufficient) (Score 1) to Clinically poor (entirely insufficient) (Score 5)

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

Philip Pradeep

Associate Professor

Melaka Manipal Medical College

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