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临床试验/NCT04061096
NCT04061096已完成不适用

Effectiveness Of Local Anesthesia In Molar Teeth With Molar Incisor Hypomineralization-A Prospective Study

Didem Sakaryali0 个研究点目标入组 38 人开始时间: 2014年9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
38
主要终点
Cold test results

研究概览

简要总结

To compare responses to electrical pulp test (EPT) and cold test among molar incisor hypomineralization (MIH)-effected and not MIH-effected carious teeth before and after administration of local anesthesia for caries removal.

详细描述

Fifty carious permanent first molar teeth (25 MIH-effected, 25 not MIH-effected) were included. Firstly, radiographic caries depth, International Caries Detection and Assessment System (ICDAS) codes and MIH levels of teeth were recorded. Then, during the treatment, EPT and cold test were performed before and after the administration of local anesthesia. Visual Analog Scale for Pain was used to evaluate cold test and pain during treatment. When interpreting results, significancy level was stated for the values of p<0.05.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

no need

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy participants

排除标准

  • Not being cooperative during treatment procedure

研究组 & 干预措施

MIH-effected carious first permanent molar teeth

Active Comparator

MIH-effected carious permanent first molar teeth were well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.

干预措施: Evaluation of cold test (Diagnostic Test)

MIH-effected carious first permanent molar teeth

Active Comparator

MIH-effected carious permanent first molar teeth were well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.

干预措施: Evaluation of electrical pulp test (Diagnostic Test)

MIH-effected carious first permanent molar teeth

Active Comparator

MIH-effected carious permanent first molar teeth were well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.

干预措施: Evaluation of pain during the treatment (Diagnostic Test)

not MIH-effected carious first permanent molar teeth

Active Comparator

The carious not MIH-effected teeth were only carious without any hypomineralize areas and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.

干预措施: Evaluation of cold test (Diagnostic Test)

not MIH-effected carious first permanent molar teeth

Active Comparator

The carious not MIH-effected teeth were only carious without any hypomineralize areas and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.

干预措施: Evaluation of electrical pulp test (Diagnostic Test)

not MIH-effected carious first permanent molar teeth

Active Comparator

The carious not MIH-effected teeth were only carious without any hypomineralize areas and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.

干预措施: Evaluation of pain during the treatment (Diagnostic Test)

not MIH-effected non-carious first permanent molar teeth

Placebo Comparator

not any signs of being caries or hypomineralization.

干预措施: Evaluation of cold test (Diagnostic Test)

MIH-effected non-carious first permanent molar teeth

Placebo Comparator

MIH-effected teeth were carious permanent first molar teeth with well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and did not have any sign of caries.

干预措施: Evaluation of cold test (Diagnostic Test)

MIH-effected non-carious first permanent molar teeth

Placebo Comparator

MIH-effected teeth were carious permanent first molar teeth with well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and did not have any sign of caries.

干预措施: Evaluation of electrical pulp test (Diagnostic Test)

MIH-effected non-carious first permanent molar teeth

Placebo Comparator

MIH-effected teeth were carious permanent first molar teeth with well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and did not have any sign of caries.

干预措施: Evaluation of pain during the treatment (Diagnostic Test)

not MIH-effected non-carious first permanent molar teeth

Placebo Comparator

not any signs of being caries or hypomineralization.

干预措施: Evaluation of electrical pulp test (Diagnostic Test)

not MIH-effected non-carious first permanent molar teeth

Placebo Comparator

not any signs of being caries or hypomineralization.

干预措施: Evaluation of pain during the treatment (Diagnostic Test)

结局指标

主要结局

Cold test results

时间窗: Time frame of cold test evaluation was aproximately 1 hour for each participant.

Visual Analog Scale for Pain was used to evaluate the cold tests for before and after the local anesthesia. Visual analog scale was used to rate the sensitivity level of patients with 6 different faces representing different levels of pain from "0=no pain" to "10=unbearable pain".

Electrical pulp test results

时间窗: Time frame of electrical pulp test evaluation was aproximately 1 hour for each participant.

Electrical pulp test values at which patients felt sensitive were recorded.

Pain during the treatment

时间窗: Pain during the treatment was evaluated for aproximately 1 hour for each participant.

Visual Analog Scale for Pain was used to evaluate the pain during the treatment. Visual analog scale was used to rate the sensitivity level of patients with 6 different faces representing different levels of pain from "0=no pain" to "10=unbearable pain".

次要结局

未报告次要终点

研究者

发起方
Didem Sakaryali
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Didem Sakaryali

Asst. Prof. Dr.

Baskent University

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