NCT03728244

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

Status unknown Phase 1/Phase 2 Last updated 1 November 2018

What this trial tests

Phase 1/Phase 2 trial testing MEBO ointment in Graft Pain in 30 participants. Status unknown.

Timeline

1 February 2019

Primary endpoint
1 November 2019

1 August 2020

Quick facts

Lead sponsor	Cairo University
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 February 2019
Primary completion	1 November 2019
Estimated completion	1 August 2020

Drugs / interventions tested

• MEBO ointment — full drug profile →
• Hyaluronic Acid gel

Conditions studied

• Graft Pain — all drugs for Graft Pain →
• Gingival Recession — all drugs for Gingival Recession →

Sponsor

Cairo University

Who can join

Adults 21 to 62, any sex, with Graft Pain or Gingival Recession. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Post operative pain: VAS
  Time frame: on day 7
  measured by Visual analogue scale between 0 and 10. (0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain )

Sponsor's own description

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?

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting SARS-CoV-2 Proteases and Polymerase for COVID-19 Treatment: State of the Art and Future Opportunities.
   Cannalire R, Cerchia C, Beccari AR, Di Leva FS, et al · · 2022 · cited 171× · PMID 33186044 · DOI 10.1021/acs.jmedchem.0c01140
2. Clinical Comparison of MEBO and Hyaluronic Acid Gel in the Management of Pain after Free Gingival Graft Harvesting: A Randomized Clinical Trial.
   Hassan A, Ahmed E, Ghalwash D, Elarab AE. · · 2021 · cited 21× · PMID 34426739 · DOI 10.1155/2021/2548665
3. Baicalin regulates stem cells as a creative point in the treatment of climacteric syndrome.
   Wei Q, Hao X, Lau BW, Wang S, et al · · 2022 · cited 5× · PMID 36408261 · DOI 10.3389/fphar.2022.986436