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

Phase 1

• Conditions: Graft Pain; Gingival Recession
• Interventions: Drug: MEBO ointment; Drug: Hyaluronic Acid gel

• Registration Number: NCT03728244
• Lead Sponsor: Cairo University

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:

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 Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-27
• Study First Submitted QC: 2018-11-01
• Last Update Submitted: 2018-11-01
• Study First Posted: 2018-11-02
• Last Update Posted: 2018-11-02
• Study Start: 2019-02
• Primary Completion: 2019-11
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with mucogingival defects scheduled for free gingival graft
• Systemically healthy

Read More

Exclusion Criteria

• Smokers
• Occlusal trauma at site of graft
• Pregnancy and lactation
• Patients allergic to the used agents
• Severe gagging reflex

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group MEBO ointment	MEBO ointment	Patients scheduled for free gingival graft harvesting will receive MEBO ointment
test group Hyaluronic acid	Hyaluronic Acid gel	Patients scheduled for free gingival graft harvesting will receive Hyaluronic acid gel 0.2%

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.