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.

NCT07330154 | Recruiting

• 2 other identifiers: 440-20252/185/2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

NBF gel; wound healing; palatal donor site; soft tissue graft

Outcome Measures

Primary Outcomes (1)

• 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.

  On each follow up visit: 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)

Secondary Outcomes (7)

• Early wound healing index (EWHI)

  On each follow up visit: 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)

• Present or abscent (Yes/no):

  On each follow up visit: 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)

• Erythema, redness + edema, swelling

  On each follow up visit: 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)

• Epithelization and exposure of CT

  On each follow up visit: 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)

• Incision margins

  On each follow up visit: 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)

Study Arms (2)

Nano bio-fusion gingival gel (NBF)

EXPERIMENTAL

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.

Drug: Application of NBF gel after soft tissue graft surgery

placebo gel

PLACEBO COMPARATOR

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.

Other: Application of placebo gel after soft tissue graft surgery

Interventions

Application of NBF gel after soft tissue graft surgery DRUG

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.

Also known as: phenotype modification, recession coverage, free gingival graft, connective tissue graft, coronal position flap, subepithelial connective tissue graft, tunnelling, lateral position flap

Nano bio-fusion gingival gel (NBF)

Application of placebo gel after soft tissue graft surgery OTHER

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.

Also known as: phenotype modification, recession coverage, free gingival graft, connective tissue graft, coronal position flap, subepithelial connective tissue graft, tunnelling, lateral position flap

placebo gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology, Faculty of Dentistry

Irbid, Irbid Governorate, 22110, Jordan

RECRUITING

MeSH Terms

Interventions

Microscopy, Scanning Tunneling

Intervention Hierarchy (Ancestors)

Microscopy, Scanning Probe; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Lana Bader, DClinDent Perio

  Jordan University of Science and Technology

  STUDY DIRECTOR

• Rand Aldurra, MClinDent Perio

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lana Bader, DClinDent Perio

CONTACT

+962791200956; lmbader4@just.edu.jo

Rand Aldurra, MClinDent Perio

CONTACT

lana.bader@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The gel will be provided in a small opaque tube. The clinician and the patient will be blinded to the type of gel used. Other doctor or dental assistant will be responsible for dispencing the gel to the patient according to the randomization sequence and the code sheet.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: The study will recriute patients require soft tissue graft surgery where the graft is harvested from the palate 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. They will be randomly assigned into 2 groups using computer generated randomization sequence: Group 1: placebo gel Group 2: NBF gel

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: October 29, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting documents will be available after publication of the main study results, for a period of one year.
• Access Criteria: Access will be granted to qualified researchers who request the data via email to the principal investigator. Researchers must sign a data use agreement ensuring ethical use, confidentiality, and prohibition of attempts to identify participants.

Locations

JO (1)