Adjunctive Use of an Antibacterial Honey Dressing for Palatal Wound Healing After Harvesting a Free Gingival Graft

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adjunctive Use of an Antibacterial Honey Dressing for Palatal Wound Healing After Harvesting a Free Gingival Graft: A Case-control Study

Conditions
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Healing Wound

Intervention / Treatment
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* Drug: Medihoney dressing
* Device: Medihoney dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be 18 years and more systemically healthy non-smoker full-mouth plaque and bleeding scores <20%, Exclusion Criteria: has history of mucogingival surgery on the palatal area pregnant women systemic antibiotics taken for at least six months has coagulation disorders (e.g. Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy) on corticosteroids, or with any systemic disease that precluded periodontal surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No dressing applied in the donor site after harvesting the graft | |
| Experimental: Test<br>An antibacterial honey dressing material (Medihoney, http://www.medihoney.com) will be applied to donor site. | Drug: Medihoney dressing<br>* 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.<br>* Other names: K101793;Device: Medihoney dressing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in length and width of the donor site | Using periodontal probe (Hu-Friedy PCPUNC 15 mm, Hu-Friedy, Chicago, IL.) | At the 1-week, 2-week and 4-week follow-up appointments | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At the 1-week |