Impact Of Molar Incisor Hypomineralization on Quality Of Life In 8-10 Year-Old Children In Kerala
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
Dr Anjali Chandran
Kannur Dental College
