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临床试验/NCT06720168
NCT06720168招募中不适用

Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin

Cardenal Herrera University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Recurrence of dental black stain

研究概览

简要总结

Black stains on the teeth, caused by the accumulation of chromogenic microorganisms that produce iron compounds, are more common in the pediatric population and have a negative impact on dental aesthetics and patients' self-esteem. The etiology of these stains remains unclear and is not related to oral hygiene. Currently, there is no definitive treatment that prevents the reappearance of these stains, and they can only be removed by mechanical removal, which can cause injuries to the tooth structure. This study aims to evaluate the effectiveness of erythritol powder air polishers, which have antimicrobial properties, compared to conventional prophylaxis in preventing the recurrence of stains.

A randomized clinical trial will be carried out with a follow-up of 12 months, during which patient satisfaction and duration of treatment will be assessed. The results of this study could provide valuable information to improve treatment and management strategies for dental stains in the affected population, thus contributing to the emotional well-being of patients and reducing damage to their tooth enamel.

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, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with 2 or more teeth with black stain

排除标准

  • Sistemic diseases
  • Patients with physical and/or cognitive impairment which prevents participation in a dental prophylaxis.
  • Use of oral antibiotics fifteen days before the intervention
  • Allergy to erythritol

结局指标

主要结局

Recurrence of dental black stain

时间窗: 3, 6, 9 and 12 months

Following dental prophylaxis (in each of the arms) the dentist will assess the recurrence of black stains at 3, 6, 9 and 12 months

次要结局

  • Patient satisfaction(Immediately after the intervention)

研究者

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

Chirag Sheth

Tenured Professor

Cardenal Herrera University

研究点 (2)

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