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.
The Effectiveness of Nano Bio Fusion Gel (NBF) on Early Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel: a Double Blinded Randomized Controlled Clinical Trial
King Abdullah University Hospital
36 participants
Oct 29, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Patients with gingival recession that is indicated for root coverage or need for phenotype modification.
- years or older.
- absence of systemic disease
- Non-smoker
- No use of antibiotics, corticosteroids, anti-inflammatory medication or hormones in the past 3 months
Exclusion Criteria3
- Pregnant or lactating woman.
- patients with immune or systemic diseases.
- Patients with an allergy to any ingredient in the gel.
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Interventions
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.
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.
Locations(1)
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NCT07330154