跳至主要内容
临床试验/NCT05768568
NCT05768568招募中不适用

Comparison of Plaque Removal Efficacy of Powered and Manual Toothbrush Among Children With Cerebral Palsy

Dow University of Health Sciences2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Oral Hygiene Status assessed by Oral Hygiene Index Simplified (OHI-S)

研究概览

简要总结

CHildren of Cerebral Palsy(CP) are at high risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth.inability to perform coordinated movements too makes brushing very difficult and hence it worsens the oral hygiene status.

Hence the objective of the study is to assess plaque removal efficacy of powered toothbrush versus manual toothbrush evaluated by improvement in oral hygiene status of patients with Cerebral Palsy CP children who meet inclusion exclusion criteria will be assessed at different time intervals via Oral hygiene index simplified (OHI-S), plaque index (PI) and gingival index (GI) Scores will be compared and analyzed from baseline, after first phase and after second phase of interventions.

详细描述

Children with cerebral palsy manifests neurologically associated muscular dysfunction. They face difficulty in maintaining posture, gait and locomotion, leading to restricted movements. They are at a higher risk of developing dental diseases most commonly periodontitis and caries. Neuromuscular and psychological impact makes it difficult for the CP child to clean dental plaque from the surface of the teeth. The main cause of dental diseases in CP is ineffective removal of dental plaque. This is due to lack of motor and neuromuscular dysfunction with an inability to understand and comprehend oral hygiene instructions and unable to carryout well-coordinated movements for instance tooth brushing. In a disadvantaged population interventions should be introduced at an early phase of life encouraging it to become part of CP child's daily oral hygiene maintenance regime.

Hence the objective of the study was designed to assess plaque removal efficacy of powered toothbrush versus manual toothbrush evaluated by improvement in oral hygiene status of patients with Cerebral Palsy CP children who will meet the inclusion criteria will be assigned into two groups. Baseline debris, calculus and gingival and plaque status will be recorded using Oral Hygiene Index Simplified (OHI-S) and gingival & plaque index (PI, GI). The group I will receive a conventional manual toothbrush and group II will be given powered toothbrush. After 4 weeks,will receive powered brush and group II will receive manual brush. After 4 weeks again the subjects will be assessed again for PI, GI, OHI-S. The scores will be compared and analyzed from baseline, after first phase and after second phase of interventions. Repeated measures two way ANOVA with Post Hoc Tukey test. Repeated measures two way ANOVA with Post Hoc Tukey test will be applied on mean GI, PI and OHI-S. Results of phase-I and phase-II will be compared and analyzed

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • CP Children aged 12-15 years
  • CP children with OHI-S score >1.3 and GI score >1 & PI score >1
  • Subjects with positive consent from schools and parents
  • Presence of at least 20 teeth in the mouth
  • Independent (mild) CP patients - who are able to perform tooth brushing under supervision assessed by caregiver's account of daily activities.
  • Mentally stable

排除标准

  • Inability to cooperate with the oral examination
  • Severe neuromuscular incoordination
  • Reluctant or Unable to comprehend consent /or withdrawal of consent
  • Participant with calculus deposits at baseline
  • Lack of Manual dexterity to perform oral hygiene
  • Underlying systemic disease
  • Participant requiring emergency dental treatment

结局指标

主要结局

Oral Hygiene Status assessed by Oral Hygiene Index Simplified (OHI-S)

时间窗: 3 months

According to this Oral Hygiene Index Simplified (OHI-S) The oral hygiene status will be classified as Good (0-1.2), Fair (1.3-3.0), Poor (3.1-6.0)

Oral Hygiene Status assessed by Gingival Index (GI)

时间窗: 3 months

Gingival status will be classified as Mild (0.1-1), Moderate (1.1-2) and Sever (2.1-3)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohsin Haider

Principal Investigator

Dow University of Health Sciences

研究点 (2)

Loading locations...

相似试验