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Completed

NCT Number: NCT07426198

The Effect of Oral Care With Propolis in COPD Patients

The study was conducted in intensive care units and included patients diagnosed with COPD. The study was conducted with a total of 60 COPD patients, 30 in the intervention group and 30 in the control group. Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol. The control group continued to receive standard oral care. Oral mucosa was assessed on days 1, 7 and 15.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Talas, Kayseri, 38039, Turkey (Türkiye)

About this study

The study was conducted in intensive care units and included patients diagnosed with COPD. The study was conducted with a total of 60 COPD patients, 30 in the intervention group and 30 in the control group. Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol. The control group continued to receive standard oral care. Oral mucosa was assessed on days 1, 7 and 15 using the World Health Organization (WHO) Oral Mucositis Scoring Index and the Oral Assessment Guide (Oral Mucosa Score, OMS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years or older,
  • diagnosed with COPD,
  • no oral mucositis at the start of the study,
  • no known allergy to bees or bee products,
  • able to speak and understand Turkish and communicate effectively,
  • conscious,
  • without any psychiatric illness,
  • without any mental or physical disability that would prevent them from answering questions,
  • individuals who volunteered to participate in the study were included in the study.

Exclusion criteria

  • individuals with a cancer diagnosis,
  • individuals receiving immunosuppressive therapy,
  • individuals receiving mechanical ventilation support,
  • individuals with altered consciousness or acute confusion,
  • individuals who did not volunteer to participate in the study were excluded from the research.

Treatment and study plan

Oral care with propolis

Other

Individuals in the intervention group were given an oral care protocol containing propolis for 15 days, in addition to the clinic's standard oral care protocol.

Primary outcomes

  1. World Health Organization Oral Mucositis Scoring Index

    Time frame: The 1st, 7th, and 15th days were evaluated.

    The WHO Oral Mucositis Scoring Index rates the severity of mucositis on a scale of 0 to 4. Grade 0 indicates no mucositis; grade 1 indicates mild mucositis, grade 2 indicates moderate mucositis, and grades 3 and 4 indicate severe mucositis.

  2. Oral Assessment Guide

    Time frame: The 1st, 7th, and 15th days were evaluated.

    Each assessment area is scored on a scale of 1, 2, or 3 points based on the severity of changes in the oral mucosa. All points obtained from the eight areas are added together to calculate the Total Oral Mucosa Score (OMP). An increase in the total score indicates worsening of oral mucosal damage and associated clinical symptoms. The lowest possible score from the guide is 8, and the highest is 24.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

THE EFFECT OF ORAL CARE WITH PROPOLIS ON THE DEVELOPMENT OF ORAL MUCOSITIS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE RECEIVING TREATMENT IN THE INTENSIVE CARE: A RANDOMIZED CONTROLLED TRIAL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

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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