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Completed

NCT Number: NCT06332846

Oral Health in Patients Hospitalized Because of Ischemic Stroke

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).

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Key information

Age range

45 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pomeranian Medical University in Szczecin

Szczecin, 70-111, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

oral examination

Other

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

Other names: study group

Primary outcomes

  1. Oral health status

    Time frame: Baseline

    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.

  2. Oral hygiene assessment

    Time frame: Baseline

    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.

  3. Periodontal status- periodontal pockets

    Time frame: Baseline

    The depth of the existing periodontal pockets in mm (up to 3mm, 3-6 mm, above 6 mm).

  4. Periodontal status-tooth mobility

    Time frame: Baseline

    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).

  5. Periodontal status- bleeding

    Time frame: Baseline

    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).

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

Assessment of Oral Health in Patients Hospitalized Because of Ischemic Stroke

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Mar 27, 2024
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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