Studying Nano Bio Fusion Gel NBF for Faster Healing of Palate Wounds After Soft Tissue Gum Surgery Compared to Placebo Gel

What this Trial Is About

Researchers are evaluating the effect of Nano-biofusion gingival gel NBF on wound healing at the palate donor site following soft tissue graft surgery. This study aims to determine if NBF gel improves healing, reduces inflammatory mediators, and lessens pain compared to a placebo gel. The trial involves adults who require soft tissue surgery for gum recession or tissue modification. The study is a double-blinded, randomized controlled clinical trial with 36 participants evenly assigned to two groups. Participants will be randomly assigned to apply either the NBF gel or a placebo gel four times daily for four weeks to the surgical wound on the palate. The gel is applied using a sterile cotton applicator, starting immediately after surgery. Oral hygiene is restricted in the surgical area for the first two weeks, and participants will use a chlorhexidine mouthwash twice daily for two weeks. The study includes clinical assessments, photographs, and wound fluid collections at specific intervals over one month. During the study, participants will undergo wound measurements and evaluations at multiple follow-up visits on days 0, 1, 2, 4, 7, 15, 21, and 30. Wound fluid samples will be collected at early time points to assess inflammatory markers. Pain levels and the use of pain medication will be recorded. The primary outcome is wound area measurement, and secondary outcomes include healing indices, redness, swelling, tissue exposure, incision margin status, patient-reported outcomes, and cytokine levels. The study lasts for one month per participant with careful monitoring by blinded examiners.

The Effectiveness of Nano Bio Fusion Gingival Gel (NBF) on Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel.