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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03728244
Collaborator
(none)
30
Enrollment
3
Arms
18
Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Drug: MEBO ointment
  • Drug: Hyaluronic Acid gel
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: test group Hyaluronic acid

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

Drug: 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.
Other Names:
  • gengigel

    		•
    Experimental: test group MEBO ointment

    Patients scheduled for free gingival graft harvesting will receive MEBO ointment

    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).
    Other Names:
  • beta-sitosterol

    		•
    No Intervention: negative control group

    Patients scheduled for free gingival graft harvesting

    Outcome Measures

    Primary Outcome Measures

    1. Post operative pain: VAS [on day 7]

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

    Secondary Outcome Measures

    1. Color match [On day 42]

      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.

    2. wound size [at day 21]

      To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 62 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ahmed Mohamed Ahmed Hassan, postgraduate student, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03728244
    Other Study ID Numbers:
    • 170992
    First Posted:
    Nov 2, 2018
    Last Update Posted:
    Nov 2, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Ahmed Mohamed Ahmed Hassan, postgraduate student, Cairo University
    mucoginival defects
    Free gingival graft
    palatal donor site
    pain
    Additional relevant MeSH terms:
    Gingival Recession
    Hyaluronic Acid

    Study Results

    No Results Posted as of Nov 2, 2018