The Effect of Oral Care With Propolis in COPD Patients
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
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2025
CompletedFirst Submitted
Initial submission to the registry
February 16, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedFebruary 23, 2026
February 1, 2026
5 months
February 16, 2026
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
World Health Organization Oral Mucositis Scoring Index
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
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.
Study Arms (2)
Propolis Oral Care Group
EXPERIMENTALIndividuals 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.
Control group
NO INTERVENTIONThe control group continued to receive standard oral care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erciyes University
Talas, Kayseri, 38039, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- instructor
Study Record Dates
First Submitted
February 16, 2026
First Posted
February 23, 2026
Study Start
January 1, 2025
Primary Completion
June 10, 2025
Study Completion
June 10, 2025
Last Updated
February 23, 2026
Record last verified: 2026-02