An interventional study of Thyme honey and Kenalog in Aphthous Stomatitis (Major) (Minor) and Treatment Compliance, sponsored by British University In Egypt. Not yet recruiting at 1 site in Egypt. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by British University In Egypt · Not applicable, Interventional, and Treatment
Recurrent aphthous stomatitis (RAS) is considered the most common oral mucosal lesion, present first in childhood or adolescence. Aphthous ulcers affect up to 25% of the general population, and 3-month recurrence rates are as high as 50%, it is more common in female, also it increases by increasing age and minor aphthous ulcers are 80% of suffered patient.
Due to the antimicrobial, anti-inflammatory, antifungal, and analgesic effects of Thyme honey, and the lack of evidence in the considered population, the present study aimed to assess the effect of honey on the pain relief in patients with minor RAU as a primary objective and to assess the healing effect of natural thyme honey on minor RAU, and the Oral Health Impact Profile (OHIP-14) as a secondary objectives.
Treatment of aphthous will usually be for three purposes: reduction of pain and inflammation, prevention of secondary infection, reduction of duration and repetition of aphthous. The most common treatments, after oral hygiene, are: use of local and oral steroids that have effect on T-lymphocytes and reduce inflammation, use of local antibiotics, for example, chlorohexidine, benzidamine, solving vitamin and mineral deficiency, such as B12, iron, folic acid, and avoidance of food allergens. Other treatments such as amelexanox, a potent inhibitor of inflammation due to mast cells and neutrophils. levamisol, talidomide are effective too.
Many factors may be involved in its progression, such as genetic predisposition, immunological abnormalities, microbial infection, psychological stress, and hormonal state. Since the etiology and pathogenesis of RAS remains unclear, there is currently no consensus regarding a definitive curative therapy. The commonly accepted treatment strategy is to lessen the pain and duration of lesions. Topical corticosteroids, antibiotics, and analgesics are highly recommended for patients with RAS.
However, longer treatment and frequent exposure to these medications may cause fungal infection and drug resistance, which may further lead to more severe adverse effects or even life-threatening complications. Natural herbal medicines as an alternative therapy for RAS have been widely used in many countries for decade. Clinical studies on the use of such remedies have reported favorable benefits to patients by reducing the discomfort and duration of ulcers.
The large volume of literatures reported the effectiveness of honey. It indicates that it may potentially be useful to treat periodontal diseases, mouth ulcers and other problems of oral health. Furthermore, the application of honey to a wound has been demonstrated to stimulate the production and release of pro-inflammatory cytokines that assist in the wound healing process, such as interleukin-1 and tumor necrosis factor-alpha. The topical application of honey to various injured tissues has also been shown to stimulate wound repair through the stimulation of growth of epithelial cells, reduction of edema, and wound debridement.
Takzaree et al in 2017 have evaluated the effects of local application of thyme honey in open cutaneous wound healing and concluded that local application of honey two times per day could boost the healing process as it reduces the inflammation, increases granulation tissue formation, and promotes angiogenesis and epithelialization, and this would eventually result in a quicker wound healing process. These antioxidants and wound healing effects have also been validated for Tulkarm honey and Thymus vulgaris honey. A recent study revealed substantial beneficial effects of Thymus vulgaris honey on skin wound healing and recommended its use in various types of wounds.
Recent research aimed to evaluate the effect of thyme honey oral gel in the prevention of chemotherapy-induced oral mucositis in patients with breast cancer with an emphasis on patient-reported symptoms. The study concluded that the use of thyme honey oral gel reduced the incidence, duration, and severity of symptoms of oral mucositis, in addition to delaying the occurrence of grade ≥2 oral mucositis.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's planned enrollment of 20 is below the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →British University In Egypt is the lead sponsor of 70 studies on the registry; 22 are open to participants now.
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The study involved patients who had a positive history of having similar oral mucosal ulcers for 3-4 months and ulcers for \<48 h.
Exclusion Criteria:
The study excluded patients with a history of associated systemic disease.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 patients will be treated by thyme honey application (100% pure natural honey, applied by themselves) on their ulcers three times a day for 7 days.
Other: Thyme honey
10 patients will be treated by kenalog in orabase (Triamcinolone acetonide 0.1% in oral paste 5g), three times a day for 7 days only.
Drug: Kenalog
Thyme honey is a rich monofloral honey variety formed by bees that collect nectar from thymus vulgaris flowers. thyme honey application (100% pure natural honey, applied by themselves) on their ulcers three times a day for 7 days
kenalog in orabase (Triamcinolone acetonide 0.1% in oral paste 5g)
Also known as: kenalog in orabase
Pain intensity
Visual Analog Scale (0-10) will be used to determine the intensity of pain on day 0, day 3, day 5, and day 7.
Time frame: 7 days.
Size of ulcers (in mm)
after starting treatment, ulcer size will be recorded on day 0, day 3, day 5, and day 7, using a calibrated dental probe with millimeter marking.
Time frame: 7 days.
The Oral Health Impact Profile (OHIP-14) questionnaire
The Oral Health Impact Profile (OHIP-14) questionnaire has been assessed 1 week after intervention. OHIP-14 utilizes a scale with five categories (1 = never, 2 = hardly ever, 3 = occasionally, 4 = fairly often, and 5 = very often). A lower score in any of the five categories indicates higher satisfaction
Time frame: 7 days
Plan to share: No — Confidentiality of data: All data will be stored in an Excel sheet for research purposes and respecting patient confidentiality. Patients have the right to withdraw from the research at any point for any reason and with no penalty subject to them.
Start is estimated for May 2024; primary completion for May 2024, 0 months later.
Of 13 interventional studies with no phase under Stomatitis, Aphthous, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's planned 0 months is below that.
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This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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British University In Egypt