The Effect of Oral Care With Propolis in COPD Patients

February 16, 2026 updated by: Sevda Korkut, TC Erciyes University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Turkey (Türkiye)
    • Kayseri
      • Talas, Kayseri, Turkey (Türkiye), 38039
        • Erciyes 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propolis Oral Care 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.
Other: Oral care with propolis
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.
No Intervention: Control group
The control group continued to receive standard oral care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The 1st, 7th, and 15th days were evaluated.
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.
The 1st, 7th, and 15th days were evaluated.

Collaborators and Investigators

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

Sponsor

TC Erciyes 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, 2025

Primary Completion (Actual)

June 10, 2025

Study Completion (Actual)

June 10, 2025

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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