MEBO Ointment and Hyaluronic Acid Gel in the Management of Pain After Free Gingival Graft Harvesting
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| ClinicalTrials.gov Identifier: NCT03728244 |
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Recruitment Status : Unknown
Verified October 2018 by Ahmed Mohamed Ahmed Hassan, Cairo University.
Recruitment status was: Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
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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 |
|---|---|---|
| Graft Pain Gingival Recession | Drug: MEBO ointment Drug: Hyaluronic Acid gel | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated 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 |
| Estimated Study Start Date : | February 2019 |
| Estimated Primary Completion Date : | November 2019 |
| Estimated Study Completion Date : | August 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: test group Hyaluronic acid
Patients scheduled for free gingival graft harvesting will receive Hyaluronic acid gel 0.2%
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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 Name: gengigel |
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Experimental: test group MEBO ointment
Patients scheduled for free gingival graft harvesting will receive MEBO ointment
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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 Name: beta-sitosterol |
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No Intervention: negative control group
Patients scheduled for free gingival graft harvesting
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- 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 )
- Color match [ Time Frame: 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.
- wound size [ Time Frame: at day 21 ]To be recorded using (UNC 15) periodontal probe to the nearest measurement of 0.5 mm , length and width only
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| Ages Eligible for Study: | 21 Years to 62 Years (Adult) |
| 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
| Responsible Party: | Ahmed Mohamed Ahmed Hassan, postgraduate student, Cairo University |
| ClinicalTrials.gov Identifier: | NCT03728244 |
| Other Study ID Numbers: |
170992 |
| First Posted: | November 2, 2018 Key Record Dates |
| Last Update Posted: | November 2, 2018 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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 |
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mucoginival defects Free gingival graft palatal donor site pain |
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Gingival Recession Gingival Diseases Periodontal Diseases Mouth Diseases Stomatognathic Diseases Periodontal Atrophy |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |