跳至主要内容
临床试验/CTRI/2024/06/068478
CTRI/2024/06/068478尚未招募Phase 3 4

Evaluation and correlation of full mouth oral rehabilitation on bite force and body mass index in early childhood caries patients: An in vivo study

Datta Meghe Institute of Higher Education1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
The bite force after completing oral rehabilitation of early childhood caries will be more than the bite force before any needful dental treatment and same for the body mass index as post treatment masticatory efficiency will be increased

研究概览

简要总结

Introduction:

Early childhood caries (ECC) is a common condition affecting children, affecting their development of phonetics, eating, aesthetics, and permanent teeth. Full mouth rehabilitation is crucial for addressing immediate dental consequences and long-term oral health. Rehabilitating bite force can help detect stomatognathic system diseases and understand mandibular movements. Untreated dental caries can lead to malnutrition, linear growth failure, and negative BMI.

Need of the study:

Bite force assessment in the full mouth rehabilitation of early childhood caries will help in measuring functionality, monitoring stability, finding issues early, ensuring treatment effectiveness, and advising any necessary adjustments for the child’s best dental health and so as to improve postoperative quality of life.

Aim:

The purpose of this present study is to analyse the probable effects of full mouth oral rehabilitation of early childhood caries (ECC) on bite forces at their maximum extent and on body mass index (BMI) in young paediatric patients with primary dentition.

Materials and Methods:

This in-vivo study will be performed in the Hospital in the “Department of Paediatric and Preventive Dentistry” at “Sharad Pawar Dental College and Hospital” Maharashtra, India. In which  maximum bite force in young children aged 4-6 years using a Portable BITE FORCE MEASUREMENT DEVICE (BYTE) will be measured at the central incisors, right and left molar regions. Anthropometric measurements of height and weight will be taken using scales, a portable stadiometer, and a calibrated electronic device. The child’s body mass index (BMI) will be determined by calculating weight and height using a known formula. Participants will undergo bite force measurements and BMI measurements before and after dental treatment, with the difference analyzed statistically. Anthropometric measurements will be taken post-treatment, and the results will be compared before and after the treatment.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Age of the child should be within the range of 4-6 years.
  • Child with primary dentition Co-operative child with Frankel behaviour rating scale, definitely positive and positive.
  • Child with at least two opposing molars.
  • Children with good psychological and physical health.

排除标准

  • Exclusion criteria: Children with special health care needs.
  • Children with developmental dental anomalies.
  • Children with temporomandibular joint disorders.
  • Children with malocclusions.
  • Children with parafunctional habits.
  • Children with traumatic injuries.

结局指标

主要结局

The bite force after completing oral rehabilitation of early childhood caries will be more than the bite force before any needful dental treatment and same for the body mass index as post treatment masticatory efficiency will be increased

时间窗: At baseline, immediately after treatment, after 1 week, 3 weeks and 6 weeks

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Rutuja Patil

Datta Meghe Institute of Higher Education and Research

研究点 (1)

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