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CTRI Number  CTRI/2021/10/037139 [Registered on: 06/10/2021] Trial Registered Prospectively
Last Modified On: 18/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Speech and Language Therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Oral hygiene protocol with spinal cord injury patient 
Scientific Title of Study   Effectiveness of oral hygiene protocol on oral health for patients with spinal cord injury 
Trial Acronym  SCI 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sayma Azad 
Designation  Student 
Affiliation  Bangladesh Health Professions Institute (BHPI) 
Address  Bangladesh Health Professions Institute(BHPI), CRP, Chapain, Savar, Dhaka



1343
Other 
Phone  01957819916  
Fax    
Email  saymaazad.slt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nahid Parvez 
Designation  Assistant Professor, Speech and language therapy department 
Affiliation  Bangladesh Health Professions Institute (BHPI) 
Address  Bangladesh Health Professions Institute(BHPI), CRP, Chapain, Savar, Dhaka



1343
Other 
Phone  01717008513  
Fax    
Email  tonmayslt_crp@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Nahid Parvez 
Designation  Assistant Professor 
Affiliation  Bangladesh Health Professions Institute (BHPI) 
Address  Bangladesh Health Professions Institute(BHPI),CRP, Chapain, Savar, Dhaka



1343
Other 
Phone  01717008513  
Fax    
Email  tonmayslt_crp@yahoo.com  
 
Source of Monetary or Material Support  
Spinal Cord Injury Unit, Centre for the Rehabilitation of the Paralysed (CRP), Mirpur, Dhaka. 
Spinal Cord Injury Unit, Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka. 
 
Primary Sponsor  
Name  Sayma Azad 
Address  Bangladesh Health Professions Institute The academic institution of Centre for the Rehabilitation of the Paralysed, CRP Chapain, Savar, Dhaka 1343 Bangladesh. 
Type of Sponsor  Other [Self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sayma Azad  Centre for the Rehabilitation of the Paralysed (CRP)  SCI Unit, CRP, Chapain, Savar, Dhaka.

 
01957819916

saymaazad.slt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S341||Other and unspecified injury of lumbar and sacral spinal cord,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral hygiene protocol  Simple Oral hygiene protocol such as care of natural teeth, denture, lip, dry mouth, Cleanliness of teeth, gum, tongue and oral cavity for 7 days 
Comparator Agent  Traditional treatment  Traditional guidelines such as advices including cleanliness of oral cavity only. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient with SCI admitted into specialized hospital (CRP), Both male & female participants of all ages.


 
 
ExclusionCriteria 
Details  Patient with severe and critical condition, Patient who have not diagnosed properly, Subjects who will unwilling to participant in this study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
As primary outcome, poor oral health including dry and chapped lips, patchy fissured and red coated tongue, dry mouth, bad breath, debris in mouth.  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="0" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/10/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Objectives: The main objective of this study is to determine the functional effect of oral hygiene protocol on oral health for the patient with spinal cord injury (SCI). The specific objectives are to evaluate the oral health of patient with spinal cord injury before and after receiving oral hygiene protocol, to assess the changes of oral health after providing the oral hygiene protocol, to determine the effect of oral hygiene protocol.

Background history: Inpatient of SCI rehabilitation, majority of patient is unable in independency to maintain their good living due to their mobility. Due to mobility, patient with SCI are unable to do proper care of oral health which may have risk of many serious oral problems such as oral plaque, dental caries, dry mouth, loose teeth, bleeding gums, cavities, or broken teeth and symptoms of toothache, sensitive teeth, chewing problems, bad breath, or unpleasant taste in mouth, reducing diet intake as well as aspirated pneumonia. Oral candidiasis, which interfered with dysphagia, may induce difficulties in chewing and swallowing in older people, reducing also dietary intake. So, a simple and inexpensive oral hygiene protocol can play an important role to overcome poor oral health.

Justification of the study: This study is the measure of effectiveness of oral hygiene program on oral health with SCI patient. It will help for the patient with spinal cord injury to minimize oral problems and make a concern about oral health care becoming a daily routine. An oral hygiene protocol and oral health assessment tool will be a very useful resource for Spinal cord injury patient in case of assessing the oral health which will become a part of assessing dysphagia and provide oral hygiene advices which will become a part of intervention of improving oral health. As SLT profession has a significant role in Spinal cord injury unit so, this newly introduced intervention will become a better enrich based on improve oral health with SCI patient.

Methods and materials: It is a quantitative type of quasi experimental study will be conducted at CRP (Savar) and study population are patient with spinal cord injury admitted in CRP. Sampling procedure is hospital based randomization method in time between 01.10.2021 to 10.01.2022. Data Collection Tools are OHAT (for non-dental professionals), oral hygiene protocol, demographic information sheet, consent form patient’s record file.

Data Collection Procedures: Experimental group conduct (pre-test) for assessment (OHAT) by a Clinical speech and language therapist (CSLT). After that, the experimental group will introduce with oral hygiene protocol at day 0. A simple oral hygiene protocol will be advised to the patient or caregivers to apply day 0 to day 7. They will apply the protocol in one week. After one week, the experimental group will conducted an assessment (post-test). From this post-test, the investigator will get to know about the effect or change of oral health.

Data Analysis: It will divided into two parts: 1st part will analyze through the descriptive statistics for participants information. Second part will applied through a computer 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 from pretest-posttest of experimental group.

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

 

 
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