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临床试验/NCT02459730
NCT02459730已完成不适用

Glass-ionomer Cement Containing Chlorhexidine for ART

University of Campinas, Brazil0 个研究点目标入组 40 人开始时间: 2013年2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
已完成
发起方
入组人数
40
主要终点
Clinical long-term effect - Survival Rate

研究概览

简要总结

This study evaluated the clinical and microbiological long-term effects of 1.25% CHX associated with GIC applied in primary molars using Atraumatic Restorative Treatment (ART) technique. Randomized controlled trial was conducted on 40 children with carious lesions that received ART either with GIC containing CHX or GIC only. Survival rate of restorations was checked at 3 days, 3 months and 1 year after their placement when the unstimulated saliva samples were collected for microbiological assessment of mutans streptococci (MS) counts. Data were analyzed using ANOVA/Tukey or Kruskal-Wallis/Mann-Whitney tests (p <0.05).

详细描述

ART treatment and follow-up:

Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique with one of the randomly selected materials: (1) GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (KM + CHX; n= 41 tooth surfaces) or (2) KetacMolar Easymix® as a control group (KM; n = 66 tooth surfaces). Material excess was removed using carver instrument and the restoration was coated with a layer of petroleum jelly. Multiple-surface cavities were filled after placement of plastic bands and wedges. Both molars (class I and II) and incisors were treated in this study and the same GIC were used for patients who had more than one carious teeth indicated to ART. The children underwent longitudinal clinical follow-up to assess physical condition (partial or complete fractures) of the restoration and the presence of primary or secondary caries at 7 days, 3 months and 1 year, according to ART evaluation criteria by Frencken et al. Children were encouraged and instructed on dental hygiene and received all other necessary oral care.

Microbiological assays:

Unstimulated whole saliva was collected after 7 days, 3 months and 1 year after treatment from each subject by direct expectoration into a 50-ml sterile container for 5-10 min. Pooled supragingival biofilm samples were collected from all buccal and lingual smooth surfaces, except from the interior of the cavities. In order to standardize plaque amount, a sterile plastic disposable inoculating loop with a circular opening of about 1 µL capacity was used for the collection. Collection was stopped when the opening was filled. Biofilm samples were placed immediately into a 1-ml centrifuge microtubes containing Tris-EDTA buffer (10 mM Tris-Hcl, 0.1 mM EDTA, pH 7.5). Collections were performed at least 1 h after feeding. Tubes were transported on ice to laboratory and processed within 2 h.

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

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

入选标准

  • •Good general health
  • •At least one cavitated dentin carious lesion in primary molars or incisors that had an opening wide enough for the smallest ART excavator access

排除标准

  • •Teeth with pulpal exposure or the presence of fistula and history of pain were excluded

研究组 & 干预措施

ART with GIC containing 1.25% CHX

Experimental

The cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).

干预措施: ART with GIC containing 1.25% CHX. (Procedure)

ART with GIC

Active Comparator

The cavities were filled with the press finger technique using KetacMolar Easymix® (control group).

干预措施: ART with GIC. (Procedure)

结局指标

主要结局

Clinical long-term effect - Survival Rate

时间窗: up to 1 year after restorative procedure

Randomized controlled trial was conducted on 40 children with carious lesions that received ART either with GIC containing CHX or GIC only. Survival rate of restorations was checked after 7 days, 3 months and 1 year of their placement.

次要结局

  • Microbiological long-term effect (microbiological assessment of mutans streptococci (MS) counts)(up to 1 year after restorative procedure)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aline R F de Castilho

Postdoctoral scholar

University of Campinas, Brazil

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