Oral Health in Patients Hospitalized Because of Ischemic Stroke

Stroke, Ischemic Clinical Trial

Official title:

Assessment of Oral Health in Patients Hospitalized Because of Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06332846
• Other study ID #: KB-0012/06/10
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: December 10, 2023

Study information

• Verified date: March 2024
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Maintaining good oral health is essential for general health and quality of life. Results of many anal-yses showed that stroke patients had poorer oral condition and worse periodontal status than control population. The aim of the study was to carry out a clinical observation concerning condition of oral health in stroke patients and healthy population. The oral health was assessed in patients with stroke and in (control group). The following elements were assessed: missing teeth, the presence of active caries foci, the presence of existing fillings and prosthetic restorations. To assess oral hygiene API (Approximal Plaque Index) was used. As part of periodontal examina-tion, the following were assessed: the presence of dental deposits, the depth of the existing periodontal pockets, tooth mobility according to Hall and Sulcus Bleeding Index during probing (SBI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 10, 2023
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 89 Years

Eligibility

Inclusion Criteria:

• first ischemic stroke, with symptoms from the anterior cerebral artery (basin of the internal carotid artery), with a significant neurological deficit (minimum 3 points according to National Institute of Health Stroke Scale (NIHSS))

Exclusion Criteria:

• aphasia, disturbances of consciousness, mental disorders- making it impossible to express informed consent,
• surgery of the salivary glands- disrupting the secretion of saliva,
• diseases that disrupt salivary secretion (diabetes mellitus, Sjogren's syndrome, condition after radio-therapy in the area of the salivary glands)

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Mouth Diseases
• Oral Disease
• Stroke
• Stroke, Ischemic

Intervention

Other:
• oral examination
The oral health was assessed in each patient enrolled in the study. The examination was performed by using dental mirror and a calibrated periodontal probe in a day ight
• oral examination
The oral health was assessed in each patient enrolled in the study. The examination was performed by using dental mirror and a calibrated periodontal probe in the artificial lightning

Locations

Country	Name	City	State
Poland	Pomeranian Medical University in Szczecin	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral health status	The study aimed to estimate and compare a condition of oral health in stroke patients during hospital stay and healthy individuals.The following elements were assessed: a number of missing teeth, active caries foci and existing fillings. Each tooth was evaluated and scored as sound, decayed (DT), extracted because of the carious pro-cess (MT), or filled due to caries (FT). The data obtained from the examination were used to calculate the DMFT index, which is the sum of DT, MT and FT, and expresses dental caries experience.	Baseline
Primary	Oral hygiene assessment	Value of API is determined in percentage, according to proportion of the number of interproximal areas with plaque to number of all assessed interproximal areas.API values between 100-70% indicate the improper oral hygiene, values between 70-40% indicate an average oral hygiene, values between 39-25% indicate quite good hygiene, and values below 25% indicate optimal oral hygiene.	Baseline
Primary	Periodontal status- periodontal pockets	The depth of the existing periodontal pockets in mm (up to 3mm, 3-6 mm, above 6 mm).	Baseline
Primary	Periodontal status-tooth mobility	Tooth mobility according to Hall (0- no mobility, 1- labio-lingual mobility up to 1mm, 2- labio-lingual mobility up to 2 mm, 3- labio-lingual and vertical mobility).	Baseline
Primary	Periodontal status- bleeding	Sulcus Bleeding Index during probing (SBI). SBI is an index of gingival inflammation in which bleeding is measured from four gingival units (mesial and distal papillary units and labial and lingual marginal units) using a periodontal probe with a 0,5 mm diameter tip. The scoring range around eight anterior teeth (four maxillary and four mandibular) is from 0 (healthy appearance and no bleeding on probing to 5 (spontaneous bleeding with marked swelling and change in colour).	Baseline