Efficacy of Recombinant Human Epidermal Growth Factor on Healing of Palatal Donor Sites: A Randomised, Controlled, Double-Blinded, Single-Centre Clinical Trial (EGF TRIAL)
Abstract
AIM
To assess the efficacy of topical rhEGF on healing outcomes at palatal soft-tissue donor sites.
MATERIALS AND METHODS
This randomised, controlled clinical trial included 60 patients who required harvesting of palatal soft-tissue grafts. Out of two groups, the intervention group received rhEGF gel (60 μg/application for 5 days) and the comparator group received a placebo gel. Wound healing was assessed by wound area reduction and palatal early healing index (PEHI). Post-operative pain was assessed using the numerical rating scale (NRS; 0-10), including donor site complications. Measurements were recorded daily for the first 5 days and at 2, 4 and 8 weeks post-operatively.
RESULTS
Fifty-five participants completed the trial, with dropouts in both groups (intervention [n = 3], control [n = 2]). The test group showed significantly faster healing, as evidenced by higher PEHI scores (p = 0.0011) and greater wound area reduction (p = 0.0057). Post-operative pain was reduced significantly in the rhEGF group, and pain was nearly absent from day 2 onwards (p = 0.0004). No adverse effects were reported in the intervention group, whereas three participants in the control group experienced prolonged post-operative pain.
CONCLUSIONS
Topical rhEGF for 5 days significantly enhanced palatal donor site healing, reduced the wound area and alleviated post-operative pain.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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