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NCT Number: NCT06481254

Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Oral Mucositis

In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gümüşhane University

Gümüşhane, 29600, Turkey (Türkiye)

About this study

Diabetes Mellitus (DM) is a chronic metabolic disease that causes serious damage to the heart, blood vessels, eyes, kidneys and nerves. Both the number of cases and the prevalence of diabetes have been increased rapidly over the past 30 years. According to the report of the International Diabetes Federation (IDF) Report, approximately 537 million people worldwide (700 million in 4045) have diabetes and 6.5 million people were reported to have died due to diabetes in 2021. In Turkey, it is estimated that approximately 9 million people (about 13.5 million in 2045) are diagnosed with diabetes and approximately 80 thousand people will die from diabetes.

Prolonged hyperglycemia in DM can lead to microvascular (nephropathy, retinopathy and neuropathy) and macrovascular (peripheral vascular disease, hypertension, cerebrovascular disease, ischaemic heart disease) complications. However, due to poorly controlled DM, complications can be seen in the oral mucosa of patients with many immunological and metabolic changes. Oral complications seen in patients with DM include hyposalivation, xerostomia, bacterial, viral and fungal infections, poor wound healing, increased severity and incidence of caries, gingivitis and periodontal disease, periapical abscess, and burning mouth syndrome (BMS). These complications can lead to the development of oral mucositis in patients.

Many pharmacological and non-pharmacological agents are used in the prevention/treatment of oral mucositis. According to the classification of the National Center for Complementary and Integrative Health (NCCAM), complementary therapies methods are divided into three groups as nutritional, psychological and physiological and other complementary approaches. However, it is reported in the literature that complementary therapies such as cryotherapy (oral cooling), honey, propolis, vitamin E, selenium, aloe vera, black mulberry, apple cider vinegar, rose water and green tea are effective in the treatment of oral mucositis. Again in the literature, there are studies in which the effect of black mulberry syrup in patients with Chronic Obstructive Pulmonary Disease (COPD), apple cider vinegar and rose water mixture in cancer patients and green tea in the treatment of oral mucositis has been proven.

Oral mucositis is one of the oral diseases that can cause oral dysfunction, dysphagia and reduced oral health-related quality of life in patients. Oral and dental health affects a person's quality of life by affecting their physiological, psychological and social functioning. However, improving oral health is part of nursing care. In order to maintain a good quality of life, it is necessary to improve awareness of oral complications that occur in patients with DM. In the literature reviewed, only one experimental study was found in cancer patients in which oral mucositis-related quality of life was evaluated. There is no international or Turkish study on the treatment of oral mucositis in patients with DM. There are also no studies comparing hawthorn vinegar, black mulberry syrup and green tea in different sample groups. In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Overs 18 years of age,
  • Voluntary participation in the study,
  • Be lucid and able to communicate,
  • Be diagnosed with DM for at least 3 months ago,
  • Willing to use either hawthorn vinegar, black mulberry syrup or green tea as a complementary treatment for oral mucositis,
  • HbA1c ≥ 7% (Wang and Hng, 2021),
  • Oral mucositis score of 14< in oral assessment.

Exclusion criteria

  • Having a known psychological disorder,
  • Having HbA1c <7%,
  • Not having oral mucositis,
  • Having hearing loss.

Treatment and study plan

Hawthorn Vinegar Group

Other

To routine oral mucositis treatment, patients with DM in the hawthorn vinegar group gargled with 1 tablespoon (10 cc) of diluted hawthorn vinegar (mixed with 40 cc water) for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Black Mulberry Syrup Group

Other

To routine oral mucositis treatment, patients with DM in the black mulberry syrup group pure black mulberry syrup for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Green Tea Group

Other

To routine oral mucositis treatment, patients with DM in the green tea group gargled with 50 cc green tea for 1 minute 15-20 minutes before meals 3 times a day for 14 days.

Primary outcomes

  1. Oral Assessment Guide (OAG)

    Time frame: 14 Days

    The "OAG" is useful for assessing and recording the individual's daily oral condition, as well as detecting the presence of mucositis and evaluating the effectiveness of treatment. The "OAG" consists of 8 categories including voice, dysphagia, lips, tongue, saliva, mucous membranes, gums and teeth/prostheses.

    "OAG" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).

  2. Oral Health Related Quality of Life Scale (OHQoL-UK)

    Time frame: 14 Days

    The 5-point Likert-type scale, which consists of a total of 16 items to determine the degree of impact of teeth, gums, mouth or prosthesis, consists of 4 dimensions: "symptom" (items 1-2), "physical condition" (items 3-7), "psychological condition" (items 8-12) and "social condition" (items 13-16). Each item in the scale is scored as "Very bad effect-1, bad effect-2, no effect-3, good effect-4, very good effect-5". The total score of the scale varies between 16-80, and a high score indicates a high level of oral and dental health-related quality of life. The Cronbach alpha value of the scale was reported as 0.94.

    "OHQoL-UK" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Collaborators

  • Bayburt University

Registry information

Official study title

Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Quality of Life Related to Oral Mucositis and Oral Health in Individuals With Diabetes: Single Blind Randomized Controlled Study

Acronym: Oral Mucositis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2024
Registry last updated
Nov 18, 2025

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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