跳至主要内容
临床试验/NCT06988098
NCT06988098招募中不适用

Evaluation of the Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Permanent Teeth: Splint Mouth Clinical Study

Tokat Gaziosmanpasa University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024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
招募中
发起方
入组人数
60
试验地点
1
主要终点
Modified Simonsen Criteria

研究概览

简要总结

Investigation of the effect of deproteinization agents on the clinical success of non-invasive fissure sealant application, which is a non-invasive method used to prevent caries formation or to stop the progression of initial caries lesions limited to enamel on tooth surfaces thought to be at high risk of caries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Patients between the ages of 6-9 who do not have any systemic problems
  • •Have a score of 3 and 4 on the Frankl Behavior Scale
  • •Do not have a habit of clenching and/or grinding their teeth
  • •Have newly erupted permanent lower first molars without caries
  • •Have an indication for fissure sealant application

排除标准

  • •Teeth with fissure sealants
  • •Teeth with developmental defects such as hypoplasia
  • •Teeth with approximal or incipient caries lesions on one or both mandibular first permanent molars
  • •Children who are not systemically healthy
  • •Uncooperative children with scores of 1 and 2 on the Frankl Behavior Scale
  • •Children and parents who refuse to attend follow-up appointments
  • •Children with parafunctional habits such as teeth grinding

研究组 & 干预措施

Sodium Hypochlorite, Wizard

Active Comparator

There are many studies in the literature showing that the use of 5.25% NaOCl as an enamel deproteinization agent is successful in positively affecting adhesion by removing organic elements from both the enamel structure and the pellicle on the enamel surface before acid application. However, sodium hypochlorite is a strong oxidizing agent and has disadvantages such as the risk of reaction in the soft tissues of the mouth, bad odor and bad taste, especially if not used carefully in pediatric dentistry, which has led to the search for an alternative material.

干预措施: application of deproteinization agents (Other)

Hypochlorous Acid, Superox

Experimental

Hypochlorous acid is produced by the body's immune system cells, neutrophilic polymorphonuclear leukocytes, as a result of oxidative reactions to overcome pathogenic microorganisms and fight infection. Recently, slightly acidic HOCl solutions, developed by electrolysis of NaOCl, have been widely used as disinfectants. Hypochlorous acid has been shown to significantly reduce the lipopolysaccharide concentration of Porphyromonas gingivalis compared to NaOCl and chlorhexidine and to be an agent tolerated by oral tissues. It has also been reported that HOCl used as a mouthwash does not produce any systemic side effects. In clinical dentistry, HOCl has been shown to be highly effective as a result of its antimicrobial and deproteinizing properties. HOCl, with its low acidity, is an antiseptic irrigant with extraordinary properties, not only exhibiting biocompatibility and low cytotoxicity, but also having rapid and highly effective antimicrobial activity in physiological concentration rang

干预措施: application of deproteinization agents (Other)

结局指标

主要结局

Modified Simonsen Criteria

时间窗: Following the sealant application, controls will be made at 6, 12, 24 and 36 months.

Modified Simonsen Criteria Score 0 Fissure sealant is completely in the mouth and there is no new caries. Score 1 Partial loss of fissure sealant, no new caries. Score 2 Partial loss of fissure sealant and new caries. Score 3 Complete loss of fissure sealant, no new caries. Score 4 Complete loss of fissure sealant and new caries.

次要结局

  • Edge Integrity Evaluation Criteria(Following the sealant application, controls will be made at 6, 12, 24 and 36 months.)

研究者

发起方
Tokat Gaziosmanpasa University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alem Coşgun

Asistant proffessor

Tokat Gaziosmanpasa University

研究点 (1)

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