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临床试验/CTRI/2024/12/078830
CTRI/2024/12/078830尚未招募3 期

Acceptance and efficacy of music augmented manual tooth brush in plaque removal among children with autism spectrum disorder- A Randomiziesd controlled trial

Dr P Sharvari Aithal1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2026年2月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
22
试验地点
1
主要终点
To compare the efficacy of plaque removal of musical tooth brush with manual tooth brush

研究概览

简要总结

Autism Spectrum Disorder (ASD) is a genetically diverse condition that significantly hampers mental and emotional development, leading to challenges in learning, communication, and social interaction.  It is characterized by  male-to-female ratio of 4 :1. The disorder involves a complex interaction between genetic inheritance and environmental factors, influenced by epigenetic mechanisms  .Children with autism also tend to prefer repetition and sameness. Whether it’s for their preferred activities, hobbies, mealtimes, or bedtime, routines come naturally to them.1

Oral problems in individuals with autism may arise from behaviours associated factors such as personal neglect, self-injurious behaviours, dietary habits, the impact of medication, resistance to dental care, inability to cooperate in dental settings, hyposensitivity to pain, and possible avoidance of social contact . They exhibit a preference for sweets and soft foods, coupled with a tendency to retain food within their mouths, particularly in areas such as the vestibule, interdental, and occlusal regions. Given these considerations, a proactive dental prevention approach is required more effective than treatment for children with autism.2

A study  by Sikarwar et al. showed that children with autism had poor oral hygiene and gingival health with a higher incidence of periodontal disease than normal children. People with ASD tend to have higher plaque and gingival index scores ,often requiring more periodontal treatments like scaling and root planning .Frequent gingivitis in people with autism is linked to a number of factors, including inconsistent brushing practices, a lack of manual skills, inadequate hand-eye coordination, poor oral health awareness, ignorance of teeth, and adverse drug reactions from several drugs used to treat various autistic symptoms4.  Dental caries is  a common oral manifestation among children with Autism Spectrum Disorder (ASD), representing a chronic condition that typically occurs over a lifetime. If left untreated, dental caries can lead to more severe clinical results such as pulp involvement and abscess formation, significantly affecting the quality of life for affected children5. The prevalence of dental caries in individuals with ASD is  high, reaching up to 77%, compared to 46% in non-ASD children. Additionally, gingivitis affects 97% of ASD children, while only 41% of their non-ASD counterparts experience this condition. Due to their specific dental needs, children with ASD necessitate preventive

Tooth brushing plays a crucial role in maintaining oral health and is considered a fundamental self-care skill. Nevertheless, there is evidence suggesting that children with Autism Spectrum Disorder (ASD) encounter challenges in their daily tooth brushing practices, as found by the study conducted by Du, Yiu, King, and colleagues (2019). Preventive educational interventions, focusing on imparting a simple, correct, and effective tooth brushing technique, may be beneficial in enhancing oral health, especially for young individuals with Autism Spectrum Disorder (ASD), as highlighted in the study by Piraneh and colleagues (2022).3

The majority of children with autism spectrum disorder (ASD) tend to resist brushing and may attempt to avoid this daily task due to perceiving it as a tedious and disliked procedure. Parents often employ various strategies such as contingency management, offering gifts, and even using bribes to motivate their children for regular brushing. However, despite these efforts, many parents struggle to instill a genuine interest in brushing for their children.6

Literature states that calming, non-lyrical, low tone, wind, and string instruments produce a soothing effect during dental treatment for patients. Recognizing the importance of cultivating the child’s interest in brushing, new devices have been introduced to make the experience enjoyable. One such innovation is the musical tooth brush. This toothbrush plays music when the child starts brushing making it cheerful process .7

So, this study will be aimed to evaluate the efficacy and acceptance of musical toothbrush with manual toothbrush in children with Autism spectrum disorder in Dakshina Kannada district, Karnataka.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Permanent first molars and central incisors that have completely erupted
  • Having a fair- to –poor oral hygiene regimen
  • Children who can tightly grasp a tooth with one palm
  • Others those are able to obey straightforward commands and fine motor gestures
  • Children who do not brush their teeth with operated tooth brush
  • Consent from the parent or guardian.

排除标准

  • Consent not given from the parent or gaurdian
  • Children that are uncooperative or unwilling to participate in the study will be excluded.
  • Those suffering from cerebral palsy or other psychiatric illnesses
  • Children who are under antiepileptic medications such as phenytoin sodium valproate, phenobarbitone, ethosuximide, methosuximide, or steroids.

结局指标

主要结局

To compare the efficacy of plaque removal of musical tooth brush with manual tooth brush

时间窗: baseline-30days, 60dyas

次要结局

  • To assess the acceptance of musical tooth brush(To evaluate the efficacy of musical toothbrush in oral hygiene status in children with ASD-1)

研究者

发起方
Dr P Sharvari Aithal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr P Sharvari Aithal

KVG Dental College and Hospital

研究点 (1)

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