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