MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting

NCT03728244 | Unknown Phase 1 DMC

• 1 other identifier: 170992
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pain as well as bleeding are the most common complications after palatal graft harvesting also postsurgical swelling have been reported , Although different agents were used to protect the denuded areas on the palate as gelatin sponge , platelet rich fibrin (PRF) , medicinal plant extract (MPE) and platelet concentrate , no gold standard can be specified for this purpose PICO Format: P: Patients with mucogingival defects that require free gingival graft. I:1. Hyaluronic acid gel 0.2% placed in the palatal donor site then covered with periodontal pack (test group I) 2.MEBO ointment placed in the palatal donor site then covered with periodontal pack (test group II) C: Periodontal pack only O: Post-operative pain T: day 3, 7, 14, 21 and 42 postoperative. Aim of the study: To compare the effect of MEBO ointment versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction after free gingival graft harvesting. Research question: Is MEBO ointment as effective as hyaluronic acid gel in the management of postoperative pain after free gingival graft harvesting in the management of mucogingival defects?

Conditions

Graft Pain; Gingival Recession

Keywords

mucoginival defects; Free gingival graft; palatal donor site; pain

Outcome Measures

Primary Outcomes (1)

• Post operative pain: VAS

  measured by Visual analogue scale between 0 and 10. (0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain )

  on day 7

Secondary Outcomes (2)

• Color match

  On day 42

• wound size

  at day 21

Study Arms (3)

test group Hyaluronic acid

EXPERIMENTAL

Patients scheduled for free gingival graft harvesting will receive Hyaluronic acid gel 0.2%

Drug: Hyaluronic Acid gel

test group MEBO ointment

EXPERIMENTAL

Patients scheduled for free gingival graft harvesting will receive MEBO ointment

Drug: MEBO ointment

negative control group

NO INTERVENTION

Patients scheduled for free gingival graft harvesting

Interventions

MEBO ointment DRUG

The pharmacological effects of MEBO are attributable to beta-sitosterol, isolated from phellodendron amurense, flavonoids mainly baicalin isolated from scutellaria baicalensis, alkaloids mainly berberine, isolated from coptis chinensi, Beeswax and sesame oil (Zhang et al., 2005).

Also known as: beta-sitosterol

test group MEBO ointment

Hyaluronic Acid gel DRUG

Hyaluronic acid is a substance that is naturally present in the human body. It is found in the highest concentrations in fluids in the eyes and joints. The hyaluronic acid that is used as medicine is extracted from rooster combs or made by bacteria in the laboratory.

Also known as: gengigel

test group Hyaluronic acid

Eligibility Criteria

• Age: 21 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with mucogingival defects scheduled for free gingival graft
• Systemically healthy

You may not qualify if:

• Smokers
• Occlusal trauma at site of graft
• Pregnancy and lactation
• Patients allergic to the used agents
• Severe gagging reflex

Sponsors & Collaborators

• Cairo University: lead

Related Publications (9)

• Ang ES, Lee ST, Gan CS, See P, Chan YH, Ng LH, Machin D. The role of alternative therapy in the management of partial thickness burns of the face--experience with the use of moist exposed burn ointment (MEBO) compared with silver sulphadiazine. Ann Acad Med Singap. 2000 Jan;29(1):7-10.

  PMID: 10748957 BACKGROUND

• Farnoush A. Techniques for the protection and coverage of the donor sites in free soft tissue grafts. J Periodontol. 1978 Aug;49(8):403-5. doi: 10.1902/jop.1978.49.8.403.

  PMID: 288907 BACKGROUND

• Fawzy El-Sayed KM, Dahaba MA, Aboul-Ela S, Darhous MS. Local application of hyaluronan gel in conjunction with periodontal surgery: a randomized controlled trial. Clin Oral Investig. 2012 Aug;16(4):1229-36. doi: 10.1007/s00784-011-0630-z. Epub 2011 Oct 20.

  PMID: 22012469 BACKGROUND

• Hammad HM, Hammad MM, Abdelhadi IN, Khalifeh MS. Effects of topically applied agents on intra-oral wound healing in a rat model: a clinical and histomorphometric study. Int J Dent Hyg. 2011 Feb;9(1):9-16. doi: 10.1111/j.1601-5037.2009.00410.x.

  PMID: 21226845 BACKGROUND

• Hirsch T, Ashkar W, Schumacher O, Steinstraesser L, Ingianni G, Cedidi CC. Moist Exposed Burn Ointment (MEBO) in partial thickness burns - a randomized, comparative open mono-center study on the efficacy of dermaheal (MEBO) ointment on thermal 2nd degree burns compared to conventional therapy. Eur J Med Res. 2008 Nov 24;13(11):505-10.

  PMID: 19073386 BACKGROUND

• Keceli HG, Aylikci BU, Koseoglu S, Dolgun A. Evaluation of palatal donor site haemostasis and wound healing after free gingival graft surgery. J Clin Periodontol. 2015 Jun;42(6):582-9. doi: 10.1111/jcpe.12404. Epub 2015 May 19.

  PMID: 25892528 BACKGROUND

• Madi M, Kassem A. Topical simvastatin gel as a novel therapeutic modality for palatal donor site wound healing following free gingival graft procedure. Acta Odontol Scand. 2018 Apr;76(3):212-219. doi: 10.1080/00016357.2017.1403648. Epub 2017 Nov 16.

  PMID: 29145771 BACKGROUND

• Patel PV, Kumar S, Vidya GD, Patel A, Holmes JC, Kumar V. 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. 2012;56(3):277-84. doi: 10.1159/000336889. Epub 2012 Apr 26.

  PMID: 22555530 BACKGROUND

• Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105.

  PMID: 28914592 BACKGROUND

MeSH Terms

Conditions

Gingival Recession; Pain

Interventions

gamma-sitosterol

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate student

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: November 2, 2018
• Study Start: February 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: August 1, 2020
• Last Updated: November 2, 2018

Record last verified: 2018-10