GingivitisNCT05114681
Oral Health Care in Stroke Patients in Tertiary Care Hospital
An observational study of Gingivitis and Periodontitis, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
To investigate oral care provision in stroke care settings in Pakistan. Stroke can have adverse effects on oral care and health. Little is known about current oral care practices in stroke care settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis, Periodontitis, Dental Hygiene
- What is being tested?
- Assessment of Oral care as per patient personal choice
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 30 Jun 2021
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Stroke
Who may be able to join
- Patient with diagnosed case of stroke
- Both gender will be included.
Who cannot join
- Patients with a known case of bleeding diathesis.
- patient not willing to participate
- patient with known head and neck cancer and oral pathology
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, Capital, 44000
About this study
Official title: Oral Care in Stroke Patients: An Observational Study of a Tertiary Care Center
To investigate oral care provision in stroke care settings in Pakistan. Stroke can have adverse effects on oral care and health. Little is known about current oral care practices in stroke care settings.
Read the detailed description
For a variety of related reasons, stroke can adversely affect oral care. Physical impairment, coordination, sensory or cognitive deficits may accompany a stroke and can impact on independent oral care. Post-stroke alterations in facial muscle mass or movement and sensory problems may result in poorly controlled dentures.
Dysphagia can contribute to oral care concerns in a number of ways. Oral intake of fluids may be restricted to reduce the risk of aspiration pneumonia, which in turn can contribute to xerostomia. Nutritional supplements, often prescribed, are high in sugar and may predispose to caries. Furthermore, because of swallowing impairment, pharmacological interventions are often administered in syrup consistency, which is sugar-based, and may also predispose to caries. Reduced swallowing ability causes ineffective clearance of bacteria and debris from the mouth leading to caries and infection.
Some pharmacological interventions in stroke care are known to have oral side effects. Oxygen therapy frequently administered in acute stroke management is known to cause mucosal drying and blistering. The absence of normal chewing patterns as a result of pain, physical or sensory impairment can also reduce salivary function. Xerostomia also causes pain, taste disturbance, chewing, and swallowing difficulties.
Speech and denture retention is also affected by inadequate saliva. This, in turn, increases plaque formation, predisposes to opportunistic oral infections, periodontal disease, and caries, conditions which place the individual at greater risk of pain, tooth loss and tooth substance loss. Chronic periodontal infection is currently being tentatively linked with the incidence of the stroke itself, while others have demonstrated a relationship with other systemic diseases including pneumonia and cardiovascular disease.
Healthcare-led oral care is a complex intervention and comprises a number of elements. These include assessment, accessing further assistance as required, and the use of appropriate equipment and cleaning methods. Knowledge is also required to assess and apply oral care at an individual level.
- Conditions
- Gingivitis, Periodontitis, Dental Hygiene
- Being tested
- Assessment of Oral care as per patient personal choice
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Oral care as per patient personal choiceOther
We just inquire from patients or attendants about products used, the timing for oral care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Dental Hygiene
assessment of dental hygiene will be done with ROAG scale
Measured: baseline
Dental care tools survey
ask about tools for dental care in stroke units
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Hassan, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Muhammad Hassan, MD, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114681
- Sponsor's protocol ID
- Dental care in stroke
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Care in Stroke Patients: An Observational Study of a Tertiary Care Center
- ClinicalTrials.gov ID
- NCT05114681
- Acronym / sponsor ID
- Dental care in stroke
- Conditions
- Gingivitis, Periodontitis, Dental Hygiene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 10 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate oral care provision in stroke care settings in Pakistan. Stroke can have adverse effects on oral care and health. Little is known about current oral care practices in stroke care settings.
Detailed description
For a variety of related reasons, stroke can adversely affect oral care. Physical impairment, coordination, sensory or cognitive deficits may accompany a stroke and can impact on independent oral care. Post-stroke alterations in facial muscle mass or movement and sensory problems may result in poorly controlled dentures.
Dysphagia can contribute to oral care concerns in a number of ways. Oral intake of fluids may be restricted to reduce the risk of aspiration pneumonia, which in turn can contribute to xerostomia. Nutritional supplements, often prescribed, are high in sugar and may predispose to caries. Furthermore, because of swallowing impairment, pharmacological interventions are often administered in syrup consistency, which is sugar-based, and may also predispose to caries. Reduced swallowing ability causes ineffective clearance of bacteria and debris from the mouth leading to caries and infection.
Some pharmacological interventions in stroke care are known to have oral side effects. Oxygen therapy frequently administered in acute stroke management is known to cause mucosal drying and blistering. The absence of normal chewing patterns as a result of pain, physical or sensory impairment can also reduce salivary function. Xerostomia also causes pain, taste disturbance, chewing, and swallowing difficulties.
Speech and denture retention is also affected by inadequate saliva. This, in turn, increases plaque formation, predisposes to opportunistic oral infections, periodontal disease, and caries, conditions which place the individual at greater risk of pain, tooth loss and tooth substance loss. Chronic periodontal infection is currently being tentatively linked with the incidence of the stroke itself, while others have demonstrated a relationship with other systemic diseases including pneumonia and cardiovascular disease.
Healthcare-led oral care is a complex intervention and comprises a number of elements. These include assessment, accessing further assistance as required, and the use of appropriate equipment and cleaning methods. Knowledge is also required to assess and apply oral care at an individual level.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Stroke
Key inclusion criteria (2 listed)
- Patient with diagnosed case of stroke
- Both gender will be included.
Key exclusion criteria (3 listed)
- Patients with a known case of bleeding diathesis.
- patient not willing to participate
- patient with known head and neck cancer and oral pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of Oral care as per patient personal choiceWe just inquire from patients or attendants about products used, the timing for oral care. | Other | – |
Primary outcome
Assessment of Dental Hygiene
Time frame: baseline
assessment of dental hygiene will be done with ROAG scale
Dental care tools survey
Time frame: baseline
ask about tools for dental care in stroke units
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: Undecided. Data will be shared at reasonable request.
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Hassan, MD principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingivitis and Periodontitis, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Dental Hygiene (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.