Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421038
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-07
Brief Title:
Efficacy of Thyme Honey in The Management of Oral Aphthous Ulcers
Sponsor:
British University In Egypt
Organization:
British University In Egypt
Study Overview
Official Title:
Efficacy of Thyme Honey in The Management of Oral Aphthous Ulcers A Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None