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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.

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Interventions: soft tissue graft (Procedure) to Application of NBF gel after soft tissue graft surgery (Drug), Application of placebo gel after soft tissue graft surgery (Other)
    • Secondary endpoints revised (7)
    • Study title expanded, about 1 word
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07330154
Lead Sponsor King Abdullah University Hospital
Collaborators: Jordan University of Science and Technology
Conditions
(from sponsor)
Wound Healing, Palatal Wound, Donor Site Complication, Inflammatory Cytokines
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov