Effect of Nano-Bio Fusion Gel on Palatal Wound Healing After Free Gingival Graft Harvest.

NCT05442359 | Completed Phase 4 DMC

• 1 other identifier: 8422
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of soft tissue grafts is to treat mucogingival defects such as exposed root surfaces or augment gingival tissue dimensions. In single or multiple root coverage procedures, autogenous grafts are considered to be the gold standard. where the palate is considered to be the most frequent site for graft harvesting, this procedure is accompanied with complications such as postoperative pain and bleeding. Despite all materials used in the literature, no proven golden standard exits. This study will compare the effect of Nano-Bio Fusion gingival gel versus natural healing with stent as a palatal dressing in the management of wound healing and pain.

Conditions

Free Gingival Graft

Keywords

Nano-Biofusion gel; Stent; Palatal Wound

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Assessment of healing using the healing index scale by Landry with scale starting from (1 for very poor healing and 5 excellent healing)

  Change in healing from baseline up to 4 weeks

Secondary Outcomes (3)

• Post-operative Pain Assessment

  14 days

• Post-operative Pain Assessment

  7 days

• Patient Satisfaction

  Day 30

Study Arms (2)

Nano-biofusion gel gingival gel (NBF)

EXPERIMENTAL

Coverage of the free gingival graft area in the palate with stent

Drug: Nano-bio fusion gingival gel

stent

ACTIVE COMPARATOR

Coverage of the free gingival graft area in the palate

Device: stent

Interventions

Nano-bio fusion gingival gel DRUG

Thin coat applied to cover the palate after free gingival graft harvest. A stent will be placed to retain its effect. Patients will receive the gel to be used at home twice daily till 3rd week and once in the 4th week

Also known as: NBF gingival gel

Nano-biofusion gel gingival gel (NBF)

stent DEVICE

Applied as a palatal stent for palatal wound

stent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Systemically healthy/controlled patients scheduled for various periodontal or peri-implant plastic surgeries, requiring palatal free gingival graft harvesting, either epithelialized or de-epithelialized.
• Compliant Patients
• Good Oral Hygiene

You may not qualify if:

• Uncontrolled systemic diseases
• Pregnancy or lactating females
• Patients with severe gagging reflex
• Patients unwilling to sign an informed consent

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

Related Publications (1)

• Abdelrehim SMM, Elbattawy WA, Ashour OAM. The effect of nano-bio fusion gingival gel versus palatal stent on the palatal wound healing after harvesting free gingival graft: a randomized controlled clinical trial. BDJ Open. 2025 Aug 11;11(1):73. doi: 10.1038/s41405-025-00360-6.

  PMID: 40790022 DERIVED

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Sara M. Abdelrehim, Bachelor

  Cairo University, faculty of dentistry

  PRINCIPAL INVESTIGATOR

• Weam El-Battawy, PHD

  Cairo University, faculty of dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 5, 2022
• Study Start: June 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)