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

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
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03728244
Enrollment
30
Registered
2018-11-02
Start date
2019-02-28
Completion date
2020-08-31
Last updated
2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Pain, Gingival Recession

Keywords

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

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?

Detailed 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.

Interventions

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 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 62 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post operative pain: VASon day 7measured by Visual analogue scale between 0 and 10. (0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain )

Secondary

MeasureTime frameDescription
Color matchOn day 42of 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.
wound sizeat day 21To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026