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临床试验/CTRI/2024/05/068013
CTRI/2024/05/068013已完成不适用

Impact Of Molar Incisor Hypomineralization on Quality Of Life In 8-10 Year-Old Children In Kerala

Dr Faizal CP1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
To assess the impact of MIH on the quality of life in children when compared to children without MIH

研究概览

简要总结

o  Introduction

MIH-affected children face a number of difficulties in their daily life.  Due to the porosity in severely affected enamel, masticatory forces break down the tooth surfaces, resulting in unprotective dentine in large atypical cavities and esthetics . These problems described above may affect oral health–related quality of life (OHRQoL) in MIH patients.

Research Question: Is there any negative impact of MIH on the quality of life in children between 8 and 10 years?

Null Hypothesis: There is no significant association between MIH and quality of life in 8–10-year-old children.

Methods Of Data Collection

This study will be conducted among school children between 8 and 10 years old in Kannur District of Kerala State. Informed consent of each subject and his/her parent/guardian will be obtained prior to the clinical oral examination and interview.

The objective of the study and the relevant details will be explained in simple language. EAPD scoring criteria (Ghanim et al., 2011) will be used for scoring MIH. As per the sample size 100 cases affected by MIH and 100 cases without MIH will be identified. Oral examinations of the children will be performed with the child in a sitting position in broad day light.

To assess the child’s quality of life, the validated Malayalam version of the CPQ8-10 will be used. The CPQ8-10 contains a total of 25 items which can be subdivided into four domains: oral symptoms (5 items), functional limitations (5 items), emotional well-being (5 items), and social well-being (10 items).

Responses are made on an ordinal scale (0=never, 1=once/twice, 2=sometimes, 3=often, 4=every day/almost every day). Higher scores refer to a worse quality of life status. Summing the response codes for the questionnaire items generates domain scores/ sub-scales and an overall CPQ-8-10 score. The instrument’s summary score ranges from 0 to 100. A summary score of zero indicates the absence of any problems, and higher CPQ scores represent more impaired quality of life.

研究设计

研究类型
Observational

入排标准

年龄范围
8.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children between 8 and 10 years of age and with fully erupted all first permanent incisors and molars.

排除标准

  • Children with systemic comorbidities, physical or mental disability, severe malocclusion, Patients undergoing orthodontic treatment, enamel developmental defects other than MIH.

结局指标

主要结局

To assess the impact of MIH on the quality of life in children when compared to children without MIH

时间窗: At baseline

次要结局

  • To access the validity of Malayalam translation of the English version of the Child Perceptions Questionnaire for children aged from 8 to 10 years old (CPQ 8-10).(At baseline)

研究者

发起方
Dr Faizal CP
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Anjali Chandran

Kannur Dental College

研究点 (1)

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