Nano-biofusion gingival gel to improve palate wound healing after gum grafts
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
We will try a nano-biofusion gingival gel (NBF) to see if it speeds healing, reduces pain, and lowers inflammation for adults who have a palatal donor wound after soft tissue gum graft surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Abdullah University Hospital Academic / other |
| Locations | 1 site (Irbid, Irbid Governorate) |
| Trial ID | NCT07330154 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled, double-blind study enrolling about 36 patients who undergo soft tissue grafting with an open palatal donor wound. Participants are randomly assigned to apply either NBF gel or a placebo gel to the palatal wound four times a day for four weeks, with clinicians and patients blinded to allocation. Clinical photos and wound measurements will be taken on days 0, 1, 2, 4, 7, 15, 21 and 30, and wound fluid samples collected on days 0, 1, 2, 4 and 7; pain levels and analgesic use will also be recorded at follow-up visits. The trial is conducted at the Faculty of Dentistry, Jordan University of Science and Technology, and aims to detect differences in wound area and inflammatory markers between groups.
Who should consider this trial
Good fit: Adults aged 18 or older without systemic disease or smoking history who need a palatal donor graft (free gingival or connective tissue graft) and have not used antibiotics, steroids, anti-inflammatories, or hormones in the prior three months are ideal candidates.
Not a fit: Patients who are pregnant or lactating, have immune or systemic diseases, are smokers, or are allergic to the gel ingredients are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the gel could speed palatal wound closure, reduce pain and inflammation, and improve recovery after soft tissue grafting.
How similar studies have performed: Topical gels and biologic dressings have shown benefit for oral wound healing in prior research, but the specific nano-biofusion gingival gel is a relatively novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Irbid, Irbid Governorate
- Jordan University of Science and Technology, Faculty of Dentistry — Irbid, Irbid Governorate, Jordan (Recruiting)
Study contacts
- Principal investigator: Rand Aldurra, MClinDent Perio — Jordan University of Science and Technology
- Study coordinator: Lana Bader, DClinDent Perio
- Email: lmbader4@just.edu.jo
- Phone: +962791200956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.