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

Primary Purpose

Healing Wound

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Medihoney dressing
Medihoney dressing
Sponsored by
Riyadh Elm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Healing Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Test

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change in length and width of the donor site
    Using periodontal probe (Hu-Friedy PCPUNC 15 mm, Hu-Friedy, Chicago, IL.)

    Secondary Outcome Measures

    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)

    Full Information

    First Posted
    February 10, 2020
    Last Updated
    February 11, 2020
    Sponsor
    Riyadh Elm University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04269694
    Brief Title
    Adjunctive Use of an Antibacterial Honey Dressing for Palatal Wound Healing After Harvesting a Free Gingival Graft
    Official Title
    Adjunctive Use of an Antibacterial Honey Dressing for Palatal Wound Healing After Harvesting a Free Gingival Graft: A Case-control Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    May 31, 2020 (Anticipated)
    Study Completion Date
    May 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Riyadh Elm University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healing Wound

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    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)
    Masking Description
    No masking
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No dressing applied in the donor site after harvesting the graft
    Arm Title
    Test
    Arm Type
    Experimental
    Arm Description
    An antibacterial honey dressing material (Medihoney, http://www.medihoney.com) will be applied to donor site.
    Intervention Type
    Drug
    Intervention Name(s)
    Medihoney dressing
    Other Intervention Name(s)
    K101793
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Medihoney dressing
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in length and width of the donor site
    Description
    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
    Secondary Outcome Measure Information:
    Title
    The level of pain and the level of discomfort
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdullah M Alrashidi, MSc
    Phone
    00966582600876
    Email
    abdullah.m.alrashidi@student.riyadh.edu.sa

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is not a plan to make IPD available
    Citations:
    Citation
    Burkhardt R, Hammerle CH, Lang NP, Research Group on Oral Soft Tissue B, Wound H. (2015) Self-reported pain perception of patients after mucosal graft harvesting in the palatal area. J Clin Periodontol 42:281-287 Chaiken, N. (2010) Pressure ulceration and the use of Active Leptospermum honey for debridement and healing. Ostomy Wound Management 56(5), 12-14. Cortellini P, Pini Prato G. (2012) Coronally advanced flap and combination therapy for root coverage. Clinical strategies based on scientific evidence and clinical experience. Periodontol 2000 59:158-84. Eltas A, Eltas SD, Uslu MO, Ersöz M. (2014) Evaluation of patient discomfort at the palatal donor site following free gingival graft procedures: A randomized controlled clinical trial. J Periodontol Implant Dent. 6:47-53. Farnoush A. (1978) Techniques for the protection and coverage of the donor sites in free soft tissue grafts. J Periodontol. 49(8):403-5. Keceli HG, Aylikci BU, Koseoglu S, Dolgun A. (2015) Evaluation of palatal donor site haemostasis and wound healing after free gingival graft surgery. J Clin Periodontol. 42(6):582-9. Lee DS, Sinno S, Khachemoune A. (2012) Honey and wound healing: an overview. Am J Clin Dermatol. 12(3):181-90. Lorenzana ER, Allen EP. (2000) The single-incision palatal harvest technique: A strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 20:297-305. Milne SD, Connolly P. (2014) The influence of different dressings on the pH of the wound environment. J Wound Care. 23(2):53-4, 56-7. Molan PC. (2006) The evidence supporting the use of honey as a wound dressing. Int J Low Extrem Wounds 5:40-54. Ozcan, M., Ucak, O., Alkaya, B., Keceli, S., Seydaoglu, G., & Haytac, M. C. (2017) Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial. International Journal of Periodontics & Restorative Dentistry, 37(5). Patel PV, Kumar S, Vidya GD, Patel A, Holmes JC, Kumar V. (2012) Cytological assessment of healing palatal donor site wounds and grafted gingival wounds after application of ozonated oil: an eighteen-month randomized controlled clinical trial. Acta Cytol. 56(3):277-84. Yıldırım S, Özener HÖ, Doğan B, Kuru B. (2017) Effect of topically-applied hyaluronic-acid on pain and palatal epithelial wound healing: An examiner-blind, randomized, controlled clinical trial. J Periodontol. 88:1-14. Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, et al. (2010) Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: A comparative randomized-controlled clinical trial. J Clin Periodontol 37:728-38.
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    Adjunctive Use of an Antibacterial Honey Dressing for Palatal Wound Healing After Harvesting a Free Gingival Graft

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