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
|
|
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
|
|
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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