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NCT Number: NCT07000604

Effect of ınhaler Use on Oral Health in COPD Patients

The aim of this study was to evaluate the effect of oral health education given to individuals diagnosed with COPD and using inhaled medication.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Çankiri Devlet Hastanesi

Çankırı, 18000, Turkey (Türkiye)

Location status: Recruiting

Location contact

BETÜL YALÇIN, 2

SUB_INVESTIGATOR

About this study

Before the research data are collected, the purpose, content, scope and duration of the research will be explained in one-to-one interviews with the participants. Verbal and written informed consent will be obtained from the participants. After the participants gave consent to the study, they will be divided into intervention and control groups by simple random sampling method. Participants will be asked to answer the questions in the data collection tools as they see fit and to answer all of the questions. The data collection form will be applied through face-to-face interviews with participants who meet the inclusion criteria. After each completed questionnaire, the researchers will check whether the answers to the survey questions are missing. When unanswered questions are identified, participants will be invited to fill in the missing information. The completion of the questionnaires and training is planned to take an average of 20-25 minutes for each participant. The experimental group will receive training intervention. No education will be given to the control group. After 3 months, an appointment will be made to evaluate oral health

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with COPD for at least 6 months,
  • Outpatient and inpatient,
  • Consent to participate in the research,
  • Not under the age of eighteen,
  • With a metered dose inhaler (MDI) in treatment,
  • No communication barriers,
  • No COPD exacerbation and/or respiratory tract infection,
  • According to the GOLD report; mild (Stage 1), moderate (Stage 2), severe (Stage 3).

Exclusion criteria

  • Diagnosed with COPD for less than 6 months,
  • Refused to participate in the research,
  • Treatment without metered dose inhalers (MDIs),
  • Uncommunicative,
  • Those who withdrew from participating in the study during data collection,
  • Not completing the survey,
  • COPD exacerbation and/or respiratory tract infection,

Treatment and study plan

Mouth Care Training

Other

Patients will be educated on how to care for their mouths after using inhaled medication.

Primary outcomes

  1. Oral Health Status with Oral Assessment Guide

    Time frame: Baseline and 3 months after intervention

    Oral health status will be assessed using the Oral Assessment Guide. After the training, the scores of the trained group and the untrained group will be compared to determine the effect of oral care training. Each change in oral health is scored between 1 and 3 points and these points are added to obtain a total score. The guide supports the creation of an oral care protocol for a patient with a deteriorated oral mucous membrane. The scores that can be obtained from the guide vary between 8 and 24. A total oral mucous membrane score (OMP) between 8 and 14 indicates "oral-mucous membrane deterioration risk", while a score between 14 and 24 indicates "oral mucous membrane deterioration". According to the oral assessment guide, individuals with low scores indicate that their oral health is good, while high scores indicate a negative change in oral health.

Secondary outcomes

  1. Medication Adherence with Medication Adherence Reporting Scale

    Time frame: Baseline and 3 months after intervention

    Patients' compliance with inhaler use will be assessed using the Medication Adherence Reporting Scale. There are 5 items in the scale. A 5-point Likert-type scale (1=always, 5=never) is used for responses. The scores that can be obtained from the scale vary between 5 and 25. An increase in the total score of the scale indicates increased medication compliance, while a decrease in the score indicates decreased medication compliance.

Study contacts

Contact information is provided by the study sponsor or research team.

BETÜL YALÇIN, 2

CONTACT

[email protected]

+905536048980

özlem bulantekin düzalan, 1

CONTACT

[email protected]

+905063801930

Sponsors and collaborators

Lead sponsor

Çankırı Karatekin University

Other

Registry information

Official study title

Effect of Inhaler Medication Use on Oral Health in COPD Patients: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2025
Registry last updated
Jun 5, 2025

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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