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

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Gingival Recession
Graft Pain

Treatments

Drug: Hyaluronic Acid gel
Drug: MEBO ointment

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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?

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

21 to 62 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

test group Hyaluronic acid
Experimental group
Description:
Patients scheduled for free gingival graft harvesting will receive Hyaluronic acid gel 0.2%
Treatment:
Drug: Hyaluronic Acid gel
test group MEBO ointment
Experimental group
Description:
Patients scheduled for free gingival graft harvesting will receive MEBO ointment
Treatment:
Drug: MEBO ointment
negative control group
No Intervention group
Description:
Patients scheduled for free gingival graft harvesting

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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