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临床试验/NCT06673888
NCT06673888
已完成
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Clinical Assessment of an Alkasite-Based Resin Composite Restorative Material Versus Resin Modified Glass Ionomer-Based Restorative Material in Class V Cavities: One Year Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 50 人2024年12月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Class V Dental Caries
发起方
Cairo University
入组人数
50
试验地点
1
主要终点
clinical assessment
状态
已完成
最后更新
上个月

概览

简要总结

This study will be conducted to evaluate the clinical assessment of an alkasite based resin composite restorative material compared to resin modified glass ionomer based restorative material in class V cavities of anterior teeth over 12 months follow up using modified USPHS criteria.

In patients with anterior cervical (class V) carious lesions, will the novel alkasite-based restorative material show similar clinical assessment as resin modified glass ionomer over a one year follow up period?

详细描述

Dental caries is a common chronic infectious illness caused by cariogenic bacteria that metabolize sugars to generate acid, which gradually demineralizes tooth structure. Dental caries is a major healthcare problem as it is the most prevalent disease worldwide. Low socioeconomic level groups are more likely to be affected by the disease and during the past thirty years, its prevalence has not considerably decreased despite being completely preventable. Non-invasive methods (such as sealing, biofilm removal, and remineralization) should be used to treat existing early caries rather than removing the dental tissue. Cavitated lesions should be arrested or managed using a minimally invasive method, such as conservative cavity designs, and repairing defective restoration rather than replacing it. Ion-releasing restorations are recognized for their biocompatibility with surrounding tissues and their fluoride-releasing capabilities, which are thought to help prevent caries by creating an oral environment that prevents the demineralization of surrounding hard tooth tissue. Resin modified glass ionomer (RMGI) is utilized for a variety of purposes, as luting agents, liners/bases, and restorative materials. The RMGI is more aesthetically pleasing than the conventional glass ionomer while maintaining the clinical benefits of the former, such as the release of fluoride, recharging capabilities, prevention of decalcification of hard tooth tissue, inhibition of bacterial acid metabolism, and ease of clinical operation. A novel family of bioactive "alkasite" restorative materials, essentially a subgroup of composite resin, represents a new era of restorative dentistry. This material is available in a capsulated form using a unique adhesive system. An alkaline filler that has the ability to release ions that neutralize acids is used in this novel material. It is stated that this substance can neutralize bacterial acids by releasing hydroxide ions and remineralize hard dental tissues by releasing calcium and fluoride. The material's release of ions may be crucial in neutralizing the effects of cariogenic bacteria, thus guarding against tooth caries. The author conducted a study to evaluate the performance of two different restorative materials in patients with class V carious lesion in upper anterior teeth where the esthetic appearances is highly recommended.

注册库
clinicaltrials.gov
开始日期
2024年12月1日
结束日期
2025年12月1日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Sarah Mokhtar Anwar Ismail

Assistant lecturer

Cairo University

入排标准

入选标准

  • • Adults (30-40Ys) with class V cavities (ICDAS 4 or 5) in upper anterior teeth.
  • Males or females.
  • Have sufficient cognitive ability to understand consent procedures.
  • Co-operative patients approving to participate in the trial.
  • Anterior tooth cervical carious lesion with ICDAS score 4 or
  • Vital upper anterior teeth with no signs or symptoms of irreversible pulpitis.
  • Mobility grade: no clinical mobility.
  • Teeth with healthy periodontium.

排除标准

  • • Disabilities.
  • Systemic diseases or severe medically compromised.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching or temporomandibular joint disorders.
  • Cognitive impairment
  • Periapical pathosis or signs of pulpal pathology.
  • Non-vital tooth.
  • Signs of pathological wear.
  • Endodontically treated tooth.
  • Severe periodontal affection or tooth indicated for extraction.

结局指标

主要结局

clinical assessment

时间窗: 12 months change from base line to six and 12 months.

Patients were evaluated immediately at baseline, then they were recalled after 6 months and after one year. Assessors were blinded to the material assignment. They evaluated restorations using modified USPHS criteria . The assessors gave a score to each restoration regarding retention succus rate. Clinical performance assessment of restorations was performed using an exploratory probe and a clinical mirror with clean, dry teeth and under direct artificial lighting. Based on Ryge's criteria (modified USPHS), were the scores as follows: Alfa (A) represented the ideal clinical situation, Bravo (B) was clinically acceptable, and Charlie (C) represented a clinically unacceptable situation (Koc Vural, 2020).

研究点 (1)

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