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临床试验/NCT07730658
NCT07730658尚未招募不适用

Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children: A Randomized Clinical Trial

Marmara University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年7月7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
56
试验地点
1
主要终点
Black Stain Score

研究概览

简要总结

The goal of this randomized clinical trial is to compare the effect of erythritol air-polishing and conventional polishing following ultrasonic scaling on the relapse of chromogenic tooth staining in children aged 4-13 years attending the Pediatric Dentistry Clinic of Marmara University Faculty of Dentistry for routine dental examination.

The main questions this study aims to answer are:

  • Does erythritol air-polishing reduce the relapse of chromogenic tooth staining compared with conventional polishing following ultrasonic scaling?
  • Is there a difference in the time to relapse of chromogenic tooth staining between the two polishing techniques?

Researchers will compare conventional polishing (prophylaxis paste and a polishing brush) following ultrasonic scaling with erythritol air-polishing performed using the EMS air-polishing device following ultrasonic scaling to determine whether one method is more effective in preventing or delaying the relapse of chromogenic tooth staining.

详细描述

Participants will:

Undergo a routine oral examination. Receive professional removal of chromogenic tooth staining using ultrasonic scaling.

Be randomly assigned to receive either conventional polishing with prophylaxis paste and a polishing brush or erythritol air-polishing using the EMS air-polishing device.

Attend follow-up visits to assess the recurrence of chromogenic tooth staining over time.

Chromogenic tooth staining will be assessed using the Qraycam.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 4-13 years.
  • Absence of oral diseases, including gingivitis and oral mucosal diseases.
  • No orthodontic appliances.
  • No history of iron supplementation or professional fluoride treatment within the previous 3 months.
  • Systemically healthy children.

排除标准

  • Presence of oral diseases, including periodontitis, salivary gland diseases, or oral mucosal diseases.
  • History of autoimmune disease.
  • Antibiotic use within the previous 3 months.
  • Consumption of tannin-containing beverages (e.g., tea, coffee, or similar beverages) within the previous 1 month.

结局指标

主要结局

Black Stain Score

时间窗: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months

Black Stain Classification (Gasparetto et al., 2003) Score Description Clinical Characteristics 0 None No black pigmentation on the tooth surface. 1. Mild Pigmented dots or thin pigmented lines parallel to the gingival margin that are not continuous. 2. Moderate Continuous pigmented lines o extending over up to one-half of the cervical third of the tooth surface. 3. Severe Pigmentation extending over more than one-half of the cervical third of the tooth surface. Black Stain Classification (Zerman et al., 2024) Score Description A Pigmented lines or dots present only on the buccal surface. B Pigmented lines or dots present on both the buccal and lingual surfaces. C Pigmented lines or dots associated with dental caries. D Recurrent pigmented lines or dots.

Participant Feedback

时间窗: Periprocedural

Pain perception during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "hurts worst." Higher scores indicate greater pain intensity (worse outcome).

Time Session

时间窗: Periprocedural

The duration of treatment is noted and compared between groups

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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