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

NCT04269694 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: FPGRP/2019/438/36
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healing Wound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The level of pain and the level of discomfort

  At the 1-week

Study Arms (2)

Control

NO INTERVENTION

No dressing applied in the donor site after harvesting the graft

Test

EXPERIMENTAL

An antibacterial honey dressing material (Medihoney, http://www.medihoney.com) will be applied to donor site.

Drug: Medihoney dressing; Device: Medihoney dressing

Interventions

Medihoney dressing DRUG

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

Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riyadh Elm University: lead

Related Publications (1)

• 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.

  BACKGROUND

Central Study Contacts

Abdullah M Alrashidi, MSc

CONTACT

00966582600876; abdullah.m.alrashidi@student.riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Board periodontics resident

Model Details: 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.

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: March 1, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share