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临床试验/CTRI/2021/10/037139
CTRI/2021/10/037139Not Applicable不适用

Effectiveness of oral hygiene protocol on oral health for patients with spinal cord injury

Sayma Azad1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年10月15日最近更新:

试验速览

阶段
不适用
状态
Not Applicable
发起方
入组人数
60
试验地点
1
主要终点
As primary outcome, poor oral health including dry and chapped lips, patchy fissured and red coated tongue, dry mouth, bad breath, debris in mouth.

研究概览

简要总结

Objectives: The main objectiveof this study is to determine the functional effect of oral hygiene protocol onoral health for the patient with spinal cord injury (SCI). The specificobjectives are to evaluate the oral health of patient with spinal cord injurybefore and after receiving oral hygiene protocol, to assess the changes of oralhealth after providing the oral hygiene protocol, to determine the effect oforal hygiene protocol.

Backgroundhistory: Inpatientof SCI rehabilitation, majority of patient is unable in independency tomaintain their good living due to their mobility. Due to mobility, patient withSCI are unable to do proper care of oral health which may have risk of manyserious oral problems such as oral plaque, dental caries, dry mouth, loose teeth,bleeding gums, cavities, or broken teeth and symptoms of toothache, sensitiveteeth, chewing problems, bad breath, or unpleasant taste in mouth, reducingdiet intake as well as aspirated pneumonia. Oral candidiasis, which interferedwith dysphagia, may induce difficulties in chewing and swallowing in olderpeople, reducing also dietary intake. So, a simple and inexpensive oral hygieneprotocol can play an important role to overcome poor oral health.

Justificationof the study: Thisstudy is the measure of effectiveness of oral hygiene program on oral healthwith SCI patient. It will help for the patient with spinal cord injury tominimize oral problems and make a concern about oral health care becoming adaily routine. An oral hygiene protocol and oral health assessment tool will bea very useful resource for Spinal cord injury patient in case of assessing theoral health which will become a part of assessing dysphagia and provide oralhygiene advices which will become a part of intervention of improving oralhealth. As SLT profession has a significant role in Spinal cord injury unit so,this newly introduced intervention will become a better enrich based on improveoral health with SCI patient.

Methodsand materials: Itis a quantitative type of quasi experimental study will be conducted atCRP (Savar) and study population are patient with spinal cord injuryadmitted in CRP. Sampling procedure is hospital based randomization methodin time between 01.10.2021 to 10.01.2022. Data Collection Tools are OHAT (fornon-dental professionals), oral hygiene protocol, demographic informationsheet, consent form patient’s record file.

**DataCollection Procedures:**Experimental group conduct (pre-test)for assessment (OHAT) by a Clinical speech and language therapist (CSLT). Afterthat, the experimental group will introduce with oral hygiene protocol at day0. A simple oral hygiene protocol will be advised to the patient or caregiversto apply day 0 to day 7. They will apply the protocol in one week. After oneweek, the experimental group will conducted an assessment (post-test). Fromthis post-test, the investigator will get to know about the effect or change oforal health.

**DataAnalysis:**Itwill divided into two parts: 1st part will analyze through the descriptivestatistics for participants information. Second part will applied through acomputer program- “Statistical package for social sciences, version 2.0 (SPSS)will used as a data analysis tool along with ‘t test’ to compare the data frompretest-posttest of experimental group.

**Conclusion:**According toliteratures,to prevent oral health and reduce oral diseases, anoral hygiene protocol plays an important role of individuals. As therefore, asimple oral hygiene programs helps to improve oral health by doing daily oralcare generating independently or help or caregivers. A simple oral hygieneprotocol can reduce the associated factors of oral disease that might be occurfor neglecting the oral care.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Investigator Blinded

入排标准

年龄范围
15.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient with SCI admitted into specialized hospital (CRP), Both male & female participants of all ages.

排除标准

  • Patient with severe and critical condition, Patient who have not diagnosed properly, Subjects who will unwilling to participant in this study.

结局指标

主要结局

As primary outcome, poor oral health including dry and chapped lips, patchy fissured and red coated tongue, dry mouth, bad breath, debris in mouth.

时间窗: 1 week

次要结局

  • Secondary outcome will be the good and improved oral health such as smooth and moist lips, normal and moist tongue, watery and free flowing saliva, absence of oral residue after implementing the oral hygiene protocol.(1 week)

研究者

发起方
Sayma Azad
申办方类型
Other [self-funded]

研究点 (1)

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