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.
Patients with gingival recession that is indicated for root coverage or need for phenotype modification.
18 years or older.
absence of systemic disease
Non-smoker
Pregnant or lactating woman.
patients with immune or systemic diseases.
Patients with an allergy to any ingredient in the gel.
Parallel
Application of NBF gel after soft tissue graft surgery
DrugAfter 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.
Application of placebo gel after soft tissue graft surgery
Other interventionAfter 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.
Wound area
The wound area of the palatal donor site will have a rectangular shape, and it will be measured in mm according to the following equation: Area = length × width UNC15 periodontal probe will be used to do the measurements at the greatest dimension horizontally and vertically. The site will be left to heal by secondary intension.
Early wound healing index (EWHI)
the amount of fibrin at the wound margin will be assessed using early wound healing index (EWHI). The index was used to assess healing after papilla preservation flap. It will be modified to use at the vertical releasing incision of the recipient site according to the following criteria: 1. complete flap closure-no fibrin line at the incision line 2. complete flap closure-fine fibrin line at the incision line 3. complete flap closure-fibrin clot at the incision line 4. incomplete flap closure-partial tissue necrosis at the incision line 5. incomplete flap closure-complete tissue necrosis at the at the incision line
Present or abscent (Yes/no):
1. Pus discharge 2. Bleeding on palpation 3. Tenderness on palpation 4. Presence of granulation tissue 5. Scar (yes/no……if yes, wider or lesser than 2 mm, contour: regular or irregular)
Erythema, redness + edema, swelling
mild \<50% of the wound area, moderate 50%, severe \>50%.
Epithelization and exposure of CT
partial or complete epithelization
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King Abdullah University Hospital
Lead sponsor
Jordan University of Science and Technology
Collaborator
