Oral MucositisNCT07426198
The Effect of Oral Care With Propolis in COPD Patients
A study testing Oral care with propolis in people with Oral Mucositis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Oral care with propolis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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).
- Conditions
- Oral Mucositis
- Being tested
- Oral care with propolis
- Keywords
- propolis, COPD, nursing, oral mucositis
- Medical subject headings
- Stomatitis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral care with propolisOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Propolis Oral Care Group | Experimental | 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. Receives: Other: Oral care with propolis |
| Control group | No intervention | The control group continued to receive standard oral care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The 1st, 7th, and 15th days were evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jan 2025
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426198
- Sponsor's protocol ID
- 73
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07426198
- Acronym / sponsor ID
- 73
- Conditions
- Oral Mucositis
- Keywords
- propolis, COPD, nursing, oral mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propolis Oral Care Group | Experimental | Other: Oral care with propolisIndividuals 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 intervention | –The control group continued to receive standard oral care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral care with propolisIndividuals 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 | Propolis Oral Care Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral care with propolis in people with Oral Mucositis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Oral Mucositis Scoring Index (time frame: The 1st, 7th, and 15th days were evaluated.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.