A Phase 4 interventional study of Medihoney dressing and Medihoney dressing in Healing Wound, sponsored by Riyadh Elm University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by Riyadh Elm University · Phase 4, Interventional, and Supportive care
This case-control study will afford a more understanding of the clinically benefits that the antibacterial honey dressing material has in palatal wound healing and the subsequent effects in post-operative morbidity.
Hard palate is considered the most common area to harvest a free gingival graft (FGG) for several periodontal plastic surgical procedures. Due to their autogenous nature, palatal grafts have excellent clinical results and are therefore superior to synthetic or allogenic grafts. An open wound at the donor site after harvesting the FGG takes two to four weeks to heal. Wound healing is a complex process containing various events. Firstly, the hemostatic phase which leads to sealing of the wound by a clot formed by platelets and other blood-derived cells in a network composed of fibrin, fibronectin, and vitronectin. Secondly, the inflammatory phase which advances a catabolic inflammatory process mediated by neutrophils and monocytes that leads to wound cleansing. Thirdly, the formation phase that originated by granulation tissue formation which is replaced by provisional connective tissue. Three major cell types are involved in this anabolic phase: (1) Endothelial cells and progenitors for the formation of capillaries. (2) Fibroblasts and myofibroblasts required for connective tissue formation and wound shrinkage. (3) Epithelial cells which contribute to re-epithelialization. Lastly, the remodeling phase which leaves a collagen-rich dense matrix containing a few cells that regenerates a stable tissue in the long term.
One of the possible complications after harvesting the FGG is the excessive post-operative morbidity which could be in the form of discomfort, pain and bleeding. These problems may affect patient quality of life and may disturb his/her daily activities such as eating, drinking or speaking. Therefore, it is of value to include patient-related outcomes in relation to quality of life measures after soft tissue grafts in clinical trials. Eltas et al. 2014 compared the effects of a periodontal dressing, the Essix retainer, the modified Essix retainer, and modified Hawley retainer on pain, chewing, speaking, and appearance. Using a periodontal dressing was associated with more pain and bleeding after one-week post-surgery; however, the speaking and appearance in the visual analog scale (VAS) scores were lower. In light of the above, retainers might be the most appropriate in terms of pain and bleeding, but less ideal for speaking and appearance comfort. In other studies, hyaluronic-acid gels as well as platelet-rich fibrin (PRF) were applied at the donor site after FGG harvesting. Both PRF and hyaluronic-acid may provide significant benefits for wound healing parameters and reduce pain. Keceli et al. 2015 evaluated the effectiveness of an herbal extract on early wound healing following FGG and found fewer incidences of primary and secondary bleeding as well as lower pain levels during the first postoperative week. In a human study Patel et al. 2012 demonstrated that ozonated oil was able to accelerate palatal wound epithelialization in a significant manner, compared with the control group.
Honey has been used for medicinal purposes since antiquity. Lee et al. 2011 noted that honey use for burn wounds has been documented in modern-day scientific journals since as early as 1933. As interest in honey for medical purposes grew, many FDA-approved products began emerging. With more interest came an increase in clinical studies examining honey for treatment of a variety of wounds, including randomized trials, case series, and cross-sectional studies from specialties ranging from dermatology and general surgery to ophthalmology.
Clinical parameters and procedures:
Patients will receive an initial periodontal examination and treatment, if necessary. Full-mouth plaque score and full-mouth bleeding score needed to be \<20% to be eligible. Surgical procedures will be performed by the same periodontist. For all measurements the same periodontal probe (Hu-Friedy PCPUNC 15 mm, Hu-Friedy, Chicago, IL.) will be used. At the donor site, anesthesia will be achieved with palatal local infiltrations, with 1.8 mL lidocaine 2% 1:100,000 epinephrine. Once the graft is harvested, pressure will be applied to the palate until hemostasis is achieved. The length and width of the donor site will be measured and recorded. In control group, no dressing material will be applied to donor site. While in test group, an antibacterial honey dressing material (Medihoney, http://www.medihoney.com) will be applied to donor site. Medihoney is a mixture of two honeys derived from Australia and New Zealand containing glucose oxidase and Leptospermum compounds which contribute to its antibacterial activity. It is licensed for wound care in Australia, Europe and the USA. It works with the body's natural processes to bathe the wound bed promoting the removal of devitalized tissue. Its low pH (3.5-4.5) helps to lower the pH within the wound environment, which has been shown to have wound healing benefits.
All patients will receive the same analgesic (ibuprofen 600 mg) immediately after the surgery. All patients will receive the same postoperative instructions. Soft diet will be recommended for all patients. Chlorhexidine 0.12% mouth rinse will be prescribed to each patient for use twice daily. Ibuprofen 600 mg will also be prescribed for the patients to consume 1 tablet orally for every 8 hours. The participants will be asked to note the level of pain, and the level of discomfort (eating, speaking, etc.) from the donor site during the first postoperative week using a 0 to 10 pain visual analog scale (VAS) score by graphic format. Discomfort was defined as irritating sensation and difficulty in eating, speaking, etc. and pain as inability to function requiring analgesics. At the 1-week, 2-week and 4-week follow-up appointments, the length and width of the donor site will be measured and recorded.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Riyadh Elm University is the lead sponsor of 24 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No dressing applied in the donor site after harvesting the graft
An antibacterial honey dressing material (Medihoney, http://www.medihoney.com) will be applied to donor site.
Drug: Medihoney dressing · Device: Medihoney dressing
Medihoney is a mixture of two honeys derived from Australia and New Zealand containing glucose oxidase and Leptospermum compounds which contribute to its antibacterial activity.
Also known as: K101793
Medihoney is a mixture of two honeys derived from Australia and New Zealand containing glucose oxidase and Leptospermum compounds which contribute to its antibacterial activity.
Change in length and width of the donor site
Using periodontal probe (Hu-Friedy PCPUNC 15 mm, Hu-Friedy, Chicago, IL.)
Time frame: At the 1-week, 2-week and 4-week follow-up appointments
The level of pain and the level of discomfort
Using 0-10 visual analog scale (no pain on the left end (0) of the scale and the "worst pain" on the right end of the scale (10)
Time frame: At the 1-week
No study locations are listed for this record.
Plan to share: No — There is not a plan to make IPD available
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Riyadh Elm University