Assessment of Oral care as per patient personal choice in Periodontitis and Gingivitis and Dental Hygiene - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Assessment of Oral care as per patient personal choice

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Pakistan
- Capital
  - Islamabad, Capital, Pakistan, 44000
    - Shaheed Zulfiqar Ali Bhutto Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Stroke

Description

Inclusion Criteria:

Patient with diagnosed case of stroke
Both gender will be included.

Exclusion Criteria:

Patients with a known case of bleeding diathesis.
patient not willing to participate
patient with known head and neck cancer and oral pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Dental Hygiene Time Frame: baseline	assessment of dental hygiene will be done with ROAG scale	baseline
Dental care tools survey Time Frame: baseline	ask about tools for dental care in stroke units	baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Investigators

Principal Investigator: Muhammad Hassan, MD, Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

October 29, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 10, 2021

Study Record Updates

Last Update Posted (Actual)