AzTrials
AzTrials

Healing WoundPhase 4NCT04269694

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

A Phase 4 study testing Medihoney dressing in people with Healing Wound, run by Riyadh Elm University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healing Wound
What is being tested?
Medihoney dressing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Mar 2020to 31 May 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • be 18 years and more
  • systemically healthy
  • non-smoker
  • full-mouth plaque and bleeding scores <20%,

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

About this study

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

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.

Read the 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.

Conditions
Healing Wound
Being tested
Medihoney dressing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medihoney dressingDrug

    Also called 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.

  • Medihoney dressingDevice

    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.

Study groups in NCT04269694
Study groupRoleWhat they receive
ControlNo interventionNo dressing applied in the donor site after harvesting the graft
TestExperimentalAn antibacterial honey dressing material (Medihoney, http://www.medihoney.com) will be applied to donor site.
Receives: Drug: Medihoney dressing; Device: Medihoney dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in length and width of the donor site

    Using periodontal probe (Hu-Friedy PCPUNC 15 mm, Hu-Friedy, Chicago, IL.)

    Measured: At the 1-week, 2-week and 4-week follow-up appointments

Secondary outcomes (1)
  1. 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)

    Measured: At the 1-week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2020
  2. Study start1 Mar 2020 (estimated)
  3. Primary completion31 May 2020 (estimated)
  4. Study completion31 May 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04269694
Sponsor's protocol ID
FPGRP/2019/438/36
Status last verified
Feb 2020
First submitted
10 Feb 2020
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No: There is not a plan to make IPD available

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Medihoney dressing in people with Healing Wound, run by Riyadh Elm University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Abdullah M Alrashidi, MSc (00966582600876, abdullah.m.alrashidi@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in length and width of the donor site (time frame: At the 1-week, 2-week and 4-week follow-up appointments). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04269694, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in