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.

Summary

The goal of this clinical trial is to assess the effect of Nano-biofusion gingival gel (NBF) on wound healing at the palatal donor site following soft tissue graft surgery and compare it to placebo gel. The main questions it aims to answer are:

* Does NBF gel enhance wound healing after graft harvesting from the palate?
* Does NBF gel reduce the number of inflammatory mediators after surgery?
* Does NBF gel reduce pain and discomfort at the palatal donor site? Researchers will compare NBF gel to a placebo (a look-alike gel that does not contain the active ingredients) to see if NBF gel enhances wound healing.

Study steps include:

* Participants will apply the assigned gel on the surgical wound 4 times a day for 4 weeks.
* Clinical photographs and measurements will be obtained on days (0, 1, 2, 4, 7, 15, 21, 30).
* Wound fluid samples will be collected on days (0, 1, 2, 4, 7).
* Participants will be asked about the level of pain and analgesic consumption on each follow-up visit.

Conditions

• Wound Healing
• Palatal Wound
• Donor Site Complication
• Inflammatory Cytokines

Interventions

DRUG

Application of NBF gel after soft tissue graft surgery

After the surgery, patients will be instructed to apply the NBF gel to the donor site on the palate for four times daily for 4 weeks. If there is a vertical releasing incision in the recipient site, the gel will be applied along that incision too. The first application will be performed immediately after surgery by the investigator using a sterile cotton applicator.

OTHER

Application of placebo gel after soft tissue graft surgery

After the surgery, patients will be instructed to apply the placebo gel to the donor site on the palate for four times daily for 4 weeks. If there is a vertical releasing incision in the recipient site, the gel will be applied along that incision too. The first application will be performed immediately after surgery by the investigator using a sterile cotton applicator.

Sponsors & Collaborators

• Jordan University of Science and Technology

  collaborator OTHER

• King Abdullah University Hospital

  lead OTHER

Principal Investigators

• Lana Bader, DClinDent Perio · Jordan University of Science and Technology

• Rand Aldurra, MClinDent Perio · Jordan University of Science and Technology

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-29

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Jordan

Study Locations