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.

King Abdullah University Hospital

Status: Enrolling

Conditions: Palatal Wound; Inflammatory Cytokines; Donor Site Complication; Wound Healing

Treatments: Other: Application of placebo gel after soft tissue graft surgery; Drug: Application of NBF gel after soft tissue graft surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07330154

2/185/2025 (Registry Identifier)

440-2025

Details and patient eligibility

About

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.

Full description

A sample size of 36 subjects, with treated 18 sites in each group should be sufficient to detect a mean difference of 1 mm of the wound area between groups. Efforts will be made to balance the number of men and women in each group (if possible).

The participants will be recruited from patients coming to dental teaching clinics at Jordan University of Science and Technology. The patients will be randomly assigned into 2 groups using computer generated randomization sequence:

Group 1: placebo gel Group 2: NBF gel

The study's purpose and procedures will be clearly communicated to all patient. Prior to examination and treatment, each participant must sign a consent form.

Patients who require a soft tissue surgery to cover gingival recession around teeth, to modify the phenotype where there is a thin gingival tissue, or to increase the width and thickness of soft tissue will be included in the study. The soft tissue graft should be obtained from the palatal donor site by free gingival graft or depithelized connective tissue graft, leaving an open wound in the palate (around 3×6 mm size) that is going to heal by secondary intesntion.

After the procedure, patients will be instructed to use the gel 4 times a day for 4 weeks by applying it to the wound and massaging the area. It will be provided in a small opaque tube. One tube should be used each day. The clinician and the patient will be blinded to the type of gel used. Another doctor or dental assistant will be responsible for dispencing the gel to the patient according to the randomization sequence and the code sheet.

Oral hygiene measures will be prohibited for the first 2 weeks in the surgical area only to not disturb the wound healing. Patients should follow their oral hygiene routine for the rest of the teeth. They will be instructed to use 0.2% chlorhexidine mouth wash twice a day for 2 weeks after surgery.

The study will last for one month for each patient. Each patient will be assessed immediately before and after the surgery and on days (0, 1, 2, 4, 7, 15, 21, 30). Clinical photographs will be taken at each time point.

Wound fluid samples (WF) will be collected at the incision area immediately after surgery and wound closure (day 0) and on days (1, 2, 4, 7). Main inflammotry mediators will be assessed.

Study steps:

• T0(intervention): Pt will sign the consent form. Sof tissue graft surgery will be performed and the graft will be obtained from the palate. The surgery is not performed by one periodontist, but the assessment and measurements are done by the same blinded examiner.

• T1 (24 hours after the surgery), T2 (2 days after the surgery), T3 (4 days after the surgery), T4 (7 days after the surgery), T5 (15 days after the surgery), T6 (21 days after the surgery), T7 (30 days after the surgery): The wound will be measured to record all the primary and secondary outcomes. The exception is made for the collection of wound fluid samples on days 15, 21 and 30. As the wound will be probably closed by then, samples will not be collected, unless there is delayed wound healing and the fluid can be drawn from the wound.

Clinical photos will be taken before surgery and anesthesia, immediately after surgery and the rest of time points.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with gingival recession that is indicated for root coverage or need for phenotype modification.
2. 18 years or older.
3. absence of systemic disease
4. Non-smoker
5. No use of antibiotics, corticosteroids, anti-inflammatory medication or hormones in the past 3 months

Exclusion criteria

1. Pregnant or lactating woman.
2. patients with immune or systemic diseases.
3. Patients with an allergy to any ingredient in the gel.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Nano bio-fusion gingival gel (NBF)

Experimental group

Description:

The gel should be applied 4 times daily for 4 weeks. After drying the surgical site in the palate with a sterile gauze, a pea size of the gel material is applied to the wound using cotton applicator. If there is a vertical relasing incision in the recipient site, the gel will be applied using the same technique.

Treatment:

Drug: Application of NBF gel after soft tissue graft surgery

placebo gel

Placebo Comparator group

Description:

The gel should be applied 4 times daily for 4 weeks. After drying the surgical site in the palate with a sterile gauze, a pea size of the gel material is applied to the wound using cotton applicator. If there is a vertical relasing incision in the recipient site, the gel will be applied using the same technique.

Treatment:

Other: Application of placebo gel after soft tissue graft surgery