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

Gingival Recession Clinical Trial

Official title:

Clinical Comparison of MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03728244
• Other study ID #: 170992
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: February 2019
• Est. completion date: August 2020

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

Interventions:

1. Hyaluronic acid gel 0.2%

2. MEBO ointment

Procedure:

The palatal sites will be anaesthetized with 0.3 ml of a solution of 4% Articaine and 0.001% Adrenalin. Graft harvesting will be performed by basic surgical techniques previously described by Miller (1982). A rectangular shaped piece of mucosa will be harvested from the area of the hard palate by a split-thickness dissection.

The graft will then be used as it on the recipient bed.

The graft dimensions will be recorded (width and length).

Denuded palatal area will then be protected using one of the following options:

1. Periodontal pack only (control group)

2. HA gel 0.2% covered with a periodontal pack (test group I)

3. MEBO ointment covered with a periodontal pack (test group II)

Postoperative instructions:

Postoperative instructions will include discontinuing toothbrushing and flossing around the surgical sites until the day of periodontal dressing removal (day 7).

Patients will be directed to consume only soft foods during the first week and to avoid any mechanical trauma.

Patients will be scheduled to be seen on days 3, 7, 14, 21 and 42.

Periodontal pack will be first removed on day 3, and donor sites will be evaluated using selected parameters in both groups.

After evaluation, HA gels together with periodontal pack will be reapplied in test group I, MEBO ointment with periodontal pack will be reapplied in test group II whereas periodontal pack only will be reapplied in control group

On day 7, the periodontal packs will be removed for reevaluation of the wound area in all groups. Thereafter, all patients will be followed up on days 14, 21 and 42 for further evaluation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 62 Years

Eligibility

Inclusion Criteria:

• Patients with mucogingival defects scheduled for free gingival graft

• Systemically healthy

Exclusion Criteria:

• Smokers

• Occlusal trauma at site of graft

• Pregnancy and lactation

• Patients allergic to the used agents

• Severe gagging reflex

Related Conditions & MeSH terms

• Gingival Recession
• Graft Pain

Intervention

Drug:
• MEBO ointment
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).
• Hyaluronic Acid gel
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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 Singapore. 2000 Jan;29(1):7-10. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yildirim S, Özener HÖ, Dogan B, Kuru B. Effect of Topically-Applied Hyaluronic-Acid on Pain and Palatal Epithelial Wound Healing: An Examiner-Blind, Randomized, Controlled Clinical Trial. J Periodontol. 2017 Sep 15:1-14. doi: 10.1902/jop.2017.170105. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Color match	of the palatal mucosa will be assessed by comparing it with that of the adjacent and opposite side by using the objective VAS (VAS score 0-10) represented by a continuous line, by a clinician blinded to the treatment group assignment.	On day 42
Secondary	wound size	To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only	at day 21