Oral Mucosal IntegrityPEG-ORALNCT07792473
Oral Care Interventions in PEG-Fed Palliative Care Patients
A study testing Ankaferd Hemostat, Benzydamine Hydrochloride 0.15% w/v oromucosal solution and Combined Oral Care Solution in people with Oral Mucosal Integrity and Palliative Care, run by University of Yalova.
Trial summary
This pilot randomized controlled trial will compare three oral care interventions in adult palliative care patients who receive enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucosal Integrity, Palliative Care, PEG Feeding
- What is being tested?
- Ankaferd Hemostat, Benzydamine Hydrochloride 0.15% w/v oromucosal solution and Combined Oral Care Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Hospitalized in the palliative care unit Receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG) and expected to continue PEG feeding during the study follow-up period Able to undergo baseline oral cavity assessment No clinical condition preventing the planned oral care intervention No known allergy or hypersensitivity to the components of the assigned oral care intervention Written informed consent provided by the patient or legally authorized representative
Who cannot join
- Active severe bleeding in the oral cavity Extensive traumatic or surgical lesions in the oral cavity that prevent implementation of the oral care intervention Severe oral mucositis or oral tissue necrosis that prevents implementation of the intervention Uncontrolled bleeding risk or clinically significant coagulopathy Terminal agitation or clinical instability that prevents safe implementation of oral care Development of a clinical condition during follow-up that requires discontinuation of the assigned oral care intervention
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Irem Ozturk Bardak, RN contact
About this study
Official title: Effects of Oral Care Interventions on Oral Mucosal Integrity in Palliative Care Patients Receiving Enteral Nutrition Via Percutaneous Endoscopic Gastrostomy: A Three-Arm Pilot Randomized Controlled Trial
This pilot randomized controlled trial will compare three oral care interventions in adult palliative care patients who receive enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube. The purpose of the study is to determine how these oral care interventions affect the health and integrity of the oral mucosa.
Participants will be randomly assigned to one of three groups: oral care with Ankaferd Hemostat, benzydamine hydrochloride, or a combined solution containing methylprednisolone, ceftriaxone, and sodium bicarbonate. Oral care will be provided by trained nurses according to a standardized protocol.
Participants' mouths will be assessed at the beginning of the study and on days 7 and 15. These assessments will include examination of the oral mucosa and standardized photographs of the mouth. Relevant clinical and laboratory information available as part of routine patient care will also be recorded. The findings will be used to compare changes in oral mucosal health among the three groups.
Read the detailed description
Patients receiving enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube may experience oral health problems because of reduced oral intake, underlying disease, functional limitations, and dependence on oral care. Maintaining oral mucosal integrity is therefore an important component of nursing care in palliative care settings.
This pilot study will evaluate and compare three oral care interventions used in clinical practice in PEG-fed palliative care patients. The study will focus on changes in oral mucosal integrity, including erythema and ulceration. The findings will provide preliminary information on the effects of these interventions and may help inform the design of a future larger randomized controlled trial.
- Conditions
- Oral Mucosal Integrity, Palliative Care, PEG Feeding
- Being tested
- Ankaferd Hemostat, Benzydamine Hydrochloride 0.15% w/v oromucosal solution, Combined Oral Care Solution
- Keywords
- Percutaneous Endoscopic Gastrostomy, Enteral Nutrition, Palliative Care, Oral Care, Oral Mucosal Integrity, Ankaferd Hemostat, Benzydamine Hydrochloride, Methylprednisolone, Ceftriaxone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankaferd HemostatDrug
Ankaferd Hemostat will be used as a topical oral care intervention. For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL. The prepared solution will be applied to the oral mucosal surfaces by a trained nurse twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed.
Benzydamine Hydrochloride 0.15% w/v oromucosal solutionDrug
Benzydamine hydrochloride 0.15% will be used as a topical oral care intervention. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days. Because participants receive enteral nutrition through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed.
Combined Oral Care SolutionDrug
A combined oral care solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate will be used as a topical oral care intervention. Ceftriaxone will be diluted with 10 mL normal saline, methylprednisolone with 5 mL normal saline, and sodium bicarbonate will be added to obtain a final volume of 25 mL. The prepared solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Ankaferd Hemostat | Experimental | Arm 1 - Ankaferd Hemostat Participants assigned to this arm will receive standardized oral care followed by topical application of Ankaferd Hemostat. For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed. Receives: Drug: Ankaferd Hemostat |
| Arm 2 - Benzydamine Hydrochloride | Experimental | Arm 2 - Benzydamine Hydrochloride Participants assigned to this arm will receive standardized oral care followed by topical application of 0.15% benzydamine hydrochloride. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days. Because participants are fed through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed. Receives: Drug: Benzydamine Hydrochloride 0.15% w/v oromucosal solution |
| Arm 3 - Combined Oral Care Solution | Experimental | Arm 3 - Combined Oral Care Solution Participants assigned to this arm will receive standardized oral care followed by topical application of a combined solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate. The final solution volume will be 25 mL and will be prepared with normal saline according to the standardized clinical preparation procedure. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed. Receives: Drug: Combined Oral Care Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Mucositis Assessment Scale (OMAS) Score
Oral mucosal integrity will be assessed using the Oral Mucositis Assessment Scale (OMAS), which evaluates ulceration/pseudomembrane and erythema at predefined oral sites. Ulceration is scored from 0 to 3 and erythema from 0 to 2, with higher scores indicating greater oral mucosal damage.
Measured: Baseline (Day 0), Day 7, and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start7 Sep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Mucosal IntegrityStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel oral care intervention groups and will remain in their assigned group throughout the 15-day study period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Collaborators
- Yalova Training and Research Hospital
- Responsible party
- Principal investigator, Yasemin Karacan, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792473
- Sponsor's protocol ID
- YKU-PEG-ORALCARE-2026-01
- Acronym
- PEG-ORAL
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the published article may be shared with qualified researchers upon reasonable request to the corresponding author and following approval of the proposed research purpose. Data will be shared in accordance with applicable ethical and institutional requirements.
Publications
Sonis ST, Eilers JP, Epstein JB, et al. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer. 1999;85(10):2103-2113. PMID: 10326686 Epstein JB, Silverman S Jr, Paggiarino DA, et al. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001;92(4):875-885. PMID: 11550161 Puhar I, Paleško Tubikanec T, Glavina S, et al. Effect of Benzydamine Hydrochloride on Dental Plaque Accumulation During Short-Term Restricted Oral Hygiene: A Randomized, Placebo-Controlled Trial. Pharmaceuticals. 2026;19:1013. Berk D, Durna Z, Akın S. Kemoterapi uygulanan kanser hastalarında ağız bakımı uygulamaları ve ağız bakım alışkanlıklarının değerlendirilmesi. Sağlık ve Toplum. 2020;30(2):54-63. Kasnak G, Fıratlı HE. Antimikrobik gargara kullanımının ağız mikrobiyotasına etkisi. In: Altındiş M, ed. Ağız Mikrobiyotası. İstanbul: Nobel Yayın Dağıtım; 2022:263-287. Dağyar K. Oral Mukoza Hastalıklarının Tedavisinde Kortikosteroid Kullanımı. Bitirme Tezi. İstanbul Üniversitesi Diş Hekimliği Fakültesi; 2021.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Care Interventions on Oral Mucosal Integrity in Palliative Care Patients Receiving Enteral Nutrition Via Percutaneous Endoscopic Gastrostomy: A Three-Arm Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07792473
- Acronym / sponsor ID
- PEG-ORAL / YKU-PEG-ORALCARE-2026-01
- Conditions
- Oral Mucosal Integrity, Palliative Care, PEG Feeding
- Keywords
- Percutaneous Endoscopic Gastrostomy, Enteral Nutrition, Palliative Care, Oral Care, Oral Mucosal Integrity, Ankaferd Hemostat, Benzydamine Hydrochloride, Methylprednisolone
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Collaborators
- Yalova Training and Research Hospital
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Aug 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.
This pilot randomized controlled trial will compare three oral care interventions in adult palliative care patients who receive enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube. The purpose of the study is to determine how these oral care interventions affect the health and integrity of the oral mucosa.
Participants will be randomly assigned to one of three groups: oral care with Ankaferd Hemostat, benzydamine hydrochloride, or a combined solution containing methylprednisolone, ceftriaxone, and sodium bicarbonate. Oral care will be provided by trained nurses according to a standardized protocol.
Participants' mouths will be assessed at the beginning of the study and on days 7 and 15. These assessments will include examination of the oral mucosa and standardized photographs of the mouth. Relevant clinical and laboratory information available as part of routine patient care will also be recorded. The findings will be used to compare changes in oral mucosal health among the three groups.
Detailed description
Patients receiving enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube may experience oral health problems because of reduced oral intake, underlying disease, functional limitations, and dependence on oral care. Maintaining oral mucosal integrity is therefore an important component of nursing care in palliative care settings.
This pilot study will evaluate and compare three oral care interventions used in clinical practice in PEG-fed palliative care patients. The study will focus on changes in oral mucosal integrity, including erythema and ulceration. The findings will provide preliminary information on the effects of these interventions and may help inform the design of a future larger randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel oral care intervention groups and will remain in their assigned group throughout the 15-day study period.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Ankaferd Hemostat | Experimental | Drug: Ankaferd HemostatArm 1 - Ankaferd Hemostat Participants assigned to this arm will receive standardized oral care followed by topical application of Ankaferd Hemostat. For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed. |
| Arm 2 - Benzydamine Hydrochloride | Experimental | Drug: Benzydamine Hydrochloride 0.15% w/v oromucosal solutionArm 2 - Benzydamine Hydrochloride Participants assigned to this arm will receive standardized oral care followed by topical application of 0.15% benzydamine hydrochloride. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days. Because participants are fed through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed. |
| Arm 3 - Combined Oral Care Solution | Experimental | Drug: Combined Oral Care SolutionArm 3 - Combined Oral Care Solution Participants assigned to this arm will receive standardized oral care followed by topical application of a combined solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate. The final solution volume will be 25 mL and will be prepared with normal saline according to the standardized clinical preparation procedure. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 years or older Hospitalized in the palliative care unit Receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG) and expected to continue PEG feeding during the study follow-up period Able to undergo baseline oral cavity assessment No clinical condition preventing the planned oral care intervention No known allergy or hypersensitivity to the components of the assigned oral care intervention Written informed consent provided by the patient or legally authorized representative
Key exclusion criteria (1 listed)
- Active severe bleeding in the oral cavity Extensive traumatic or surgical lesions in the oral cavity that prevent implementation of the oral care intervention Severe oral mucositis or oral tissue necrosis that prevents implementation of the intervention Uncontrolled bleeding risk or clinically significant coagulopathy Terminal agitation or clinical instability that prevents safe implementation of oral care Development of a clinical condition during follow-up that requires discontinuation of the assigned oral care intervention
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 |
|---|---|---|
| Ankaferd HemostatAnkaferd Hemostat will be used as a topical oral care intervention. For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL. The prepared solution will be applied to the oral mucosal surfaces by a trained nurse twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed. | Drug | Arm 1 - Ankaferd Hemostat |
| Benzydamine Hydrochloride 0.15% w/v oromucosal solutionBenzydamine hydrochloride 0.15% will be used as a topical oral care intervention. The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days. Because participants receive enteral nutrition through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed. | Drug | Arm 2 - Benzydamine Hydrochloride |
| Combined Oral Care SolutionA combined oral care solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate will be used as a topical oral care intervention. Ceftriaxone will be diluted with 10 mL normal saline, methylprednisolone with 5 mL normal saline, and sodium bicarbonate will be added to obtain a final volume of 25 mL. The prepared solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days. The solution will not be swallowed. | Drug | Arm 3 - Combined Oral Care Solution |
Primary outcome
Change in Oral Mucositis Assessment Scale (OMAS) Score
Time frame: Baseline (Day 0), Day 7, and Day 15
Oral mucosal integrity will be assessed using the Oral Mucositis Assessment Scale (OMAS), which evaluates ulceration/pseudomembrane and erythema at predefined oral sites. Ulceration is scored from 0 to 3 and erythema from 0 to 2, with higher scores indicating greater oral mucosal damage.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- BackgroundSonis ST, Eilers JP, Epstein JB, et al. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer. 1999;85(10):2103-2113. PMID: 10326686 Epstein JB, Silverman S Jr, Paggiarino DA, et al. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001;92(4):875-885. PMID: 11550161 Puhar I, Paleško Tubikanec T, Glavina S, et al. Effect of Benzydamine Hydrochloride on Dental Plaque Accumulation During Short-Term Restricted Oral Hygiene: A Randomized, Placebo-Controlled Trial. Pharmaceuticals. 2026;19:1013. Berk D, Durna Z, Akın S. Kemoterapi uygulanan kanser hastalarında ağız bakımı uygulamaları ve ağız bakım alışkanlıklarının değerlendirilmesi. Sağlık ve Toplum. 2020;30(2):54-63. Kasnak G, Fıratlı HE. Antimikrobik gargara kullanımının ağız mikrobiyotasına etkisi. In: Altındiş M, ed. Ağız Mikrobiyotası. İstanbul: Nobel Yayın Dağıtım; 2022:263-287. Dağyar K. Oral Mukoza Hastalıklarının Tedavisinde Kortikosteroid Kullanımı. Bitirme Tezi. İstanbul Üniversitesi Diş Hekimliği Fakültesi; 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the published article may be shared with qualified researchers upon reasonable request to the corresponding author and following approval of the proposed research purpose. Data will be shared in accordance with applicable ethical and institutional requirements.
Related trials for Oral Mucosal Integrity
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.
Irem Ozturk Bardak, RN contact
Questions about this trial
What is this clinical trial studying?
A study testing Ankaferd Hemostat, Benzydamine Hydrochloride 0.15% w/v oromucosal solution and Combined Oral Care Solution in people with Oral Mucosal Integrity and Palliative Care, run by University of Yalova.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin Karacan, PhD (05327141814, jblacksoul@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oral Mucositis Assessment Scale (OMAS) Score (time frame: Baseline (Day 0), Day 7, and Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07792473, which also lists 1 linked publication.
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 1 Sep 2026.