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临床试验/NCT04749654
NCT04749654已完成不适用

EFFECTS OF SPACE MAINTAINERS ON THE SALIVARY pH, FLOW RATE, STREPTOCOCCUS MUTANS AND LACTOBACILLUS CARRIAGE: AN IN VİVO STUDY

TC Erciyes University0 个研究点目标入组 38 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
主要终点
FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

研究概览

简要总结

Space maintainers are used to preserve the space after premature loss of teeth but they could effect some factors that play a role in caries formation. The research aimed to assess the impacts of removable and fixed space maintainers on the salivary pH, flow rate, and Streptococcus mutans, Lactobacillus carriage.

详细描述

Although the usage of space maintainers can reduce the severity of problems that arise from the early loss of teeth, there are concerns regarding the impact of fixed and removable appliances on factors that can lead to dental caries. All space maintainer appliances are plaque retentive since bands and brackets increase the retention of plaque and food on tooth surfaces, reduce the clearance of plaque by saliva and make conventional oral hygiene for plaque removal more difficult, therefore, they may cause caries development.Space maintainers can favor caries formation by changing the oral microflora. patients aged between 4-10 years, each of whom had an indication for a fixed (n=19) or removable space maintainer (n=19), were enrolled in this research. The salivary pH, saliva flow rate, Streptococcus mutans and Lactobacillus counts in saliva were measured just prior to the application of space maintainers (baseline-T0) and in the course of the follow-up; at the 1st (T1), 3rd (T2), and 6th (T3) months. The Wilcoxon, Mann-Whithney U test and Friedman tests were used for statistical analyses.

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
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The present research was conducted on 38 patients aged between 4-10 years, each of whom had an indication for a fixed or removable space maintainer.

排除标准

  • Patients with a medical history that could influence microorganism carriage, including systemic disease, immunosuppression and the usage of antibiotics in the preceding 15 days, were excluded from the research

结局指标

主要结局

FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

时间窗: baseline-6 th month measure assessing change

Salivary pH was measured by pH meter (pH= -log hydrogen ion)

FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVA FLOW RATE, WERE MEASURED

时间窗: baseline-3rd month measure assessing change

Saliva flow rate was computed in ml/ min

FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED

时间窗: baseline-6 th month measure assessing change

Saliva flow rate was computed in ml/ min

FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY pH WERE MEASURED

时间窗: baseline-6 th month measure assessing change

Salivary pH was measured by pH meter (pH= -log hydrogen ion)

FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE LACTOBACILLUS COUNTS WERE MEASURED

时间窗: baseline-1st month measure assessing change

Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY FLOW RATE WERE MEASURED

时间窗: baseline-6 th month measure assessing change

Saliva flow rate was computed in ml/ min

FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED

时间窗: baseline-6 th month measure assessing change

Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)

FOR FıXED SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED

时间窗: baseline-6 th month measure assessing change

Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY STREPTOCOCCUS MUTANS COUNTS WERE MEASURED

时间窗: baseline-6 th month measure assessing change

Strep. mutans were counted by numbers of colony-forming units (CFU) per ml (milliliter)

FOR REMOVABLE SPACE MAıNTAıNERS: CHANGES ON THE SALIVARY LACTOBACILLUS COUNTS WERE MEASURED

时间窗: baseline-6 th month measure assessing change

Lactobacilli were counted by numbers of colony-forming units (CFU) per ml (milliliter)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

esra kizilci

DDS. PhD. Assistant Prof. Dr

TC Erciyes University

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