search
Back to results

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

Primary Purpose

Graft Pain, Gingival Recession

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MEBO ointment
Hyaluronic Acid gel
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Graft Pain focused on measuring mucoginival defects, Free gingival graft, palatal donor site, pain

Eligibility Criteria

21 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    test group Hyaluronic acid

    test group MEBO ointment

    negative control group

    Arm Description

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

    Patients scheduled for free gingival graft harvesting will receive MEBO ointment

    Patients scheduled for free gingival graft harvesting

    Outcomes

    Primary Outcome Measures

    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 )

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 27, 2018
    Last Updated
    November 1, 2018
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03728244
    Brief Title
    MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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?
    Detailed Description
    Interventions: Hyaluronic acid gel 0.2% 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: Periodontal pack only (control group) HA gel 0.2% covered with a periodontal pack (test group I) 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Graft Pain, Gingival Recession
    Keywords
    mucoginival defects, Free gingival graft, palatal donor site, pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    test group Hyaluronic acid
    Arm Type
    Experimental
    Arm Description
    Patients scheduled for free gingival graft harvesting will receive Hyaluronic acid gel 0.2%
    Arm Title
    test group MEBO ointment
    Arm Type
    Experimental
    Arm Description
    Patients scheduled for free gingival graft harvesting will receive MEBO ointment
    Arm Title
    negative control group
    Arm Type
    No Intervention
    Arm Description
    Patients scheduled for free gingival graft harvesting
    Intervention Type
    Drug
    Intervention Name(s)
    MEBO ointment
    Other Intervention Name(s)
    beta-sitosterol
    Intervention Description
    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).
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronic Acid gel
    Other Intervention Name(s)
    gengigel
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Post operative pain: VAS
    Description
    measured by Visual analogue scale between 0 and 10. (0: no pain, 1: minimal pain, 5:moderate pain, 10: severe pain )
    Time Frame
    on day 7
    Secondary Outcome Measure Information:
    Title
    Color match
    Description
    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.
    Time Frame
    On day 42
    Title
    wound size
    Description
    To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only
    Time Frame
    at day 21

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    62 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    10748957
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    288907
    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. doi: 10.1902/jop.1978.49.8.403.
    Results Reference
    background
    PubMed Identifier
    22012469
    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.
    Results Reference
    background
    PubMed Identifier
    21226845
    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.
    Results Reference
    background
    PubMed Identifier
    19073386
    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.
    Results Reference
    background
    PubMed Identifier
    25892528
    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.
    Results Reference
    background
    PubMed Identifier
    29145771
    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.
    Results Reference
    background
    PubMed Identifier
    22555530
    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.
    Results Reference
    background
    PubMed Identifier
    28914592
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs