The effect of nano-bio fusion gingival gel versus palatal stent on the palatal wound healing after harvesting free gingival graft: a randomized controlled clinical trial.

INTRODUCTION

This study aimed to compare two different approaches for palatal wound healing following free gingival graft (FGG) harvesting: one involving Nano Bio-Fusion (NBF) gingival gel used in conjunction with a palatal stent, and the other using a palatal stent alone. Outcomes were assessed in terms of wound healing, post-operative pain, and patient satisfaction.

METHODS

This parallel-grouped, two-arm, single-blinded, randomized controlled trial (RCT) included twenty-six patients with mucogingival defects that required harvesting an epithelialized free gingival graft (FGG). Patients were randomly allocated into either test group (NBF gingival gel and palatal stent; n = 13) or control group (palatal stent only; n = 13). Wound healing, the primary outcome, was evaluated over a 30-day period, while secondary outcomes included post-operative pain-measured using the Visual Analog Scale (VAS) and analgesic consumption-and patient satisfaction.

RESULTS

In the test group, wound healing showed statistically significant higher healing index score than control group after 3 days (P = 0.017), then no statistical significance was noted. Regarding post-operative pain, the test group showed statistically significantly lower pain scores (VAS) than control group in the first week, followed by no statistical significance in the second week. In the third day, the test group showed statistically significant lower analgesic consumption dose (P = 0.024) with overall statistically significant higher satisfaction score than control group (P = 0.002).

CONCLUSION

Within the limitations of this study, the results suggest that NBF gingival gel may promote early-stage palatal wound healing, reduce postoperative pain and analgesic consumption during the first week, and enhance overall patient satisfaction.

CLINICAL TRIAL REGISTRATION

(NCT05442359 | | https://www.

CLINICALTRIALS

gov/ 30-June-2022).