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

The Effect of Nano-Bio Fusion Gingival Gel Versus Natural Healing on the Palatal Wound Healing After Harvesting Free Gingival Graft.

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.

Study Overview

• Status: Recruiting
• Conditions: Free Gingival Graft
• Intervention / Treatment: Drug: Nano-bio fusion gingival gel; Device: stent

Detailed Description

In the literature, there are many modalities proposed in an attempt to decrease such complications such as the use of PRF, non-eugenol dressing Coe-pack, medicinal plant extract, hyaluronic acid. Despite all, no proven gold standard exits.

Nano- Bio Fusion gel is a highly functional paste containing (nano vitamin C, nano vitamin E and propolis extract) that was used before as an adjunct to scaling and root planning in the management of chronic periodontitis.

Owing to its natural composition, Vitamin C enhances the synthesis, maturation, secretion and degradation of collagen. Also, propolis extract is mainly composed of flavonoids possessing antimicrobial, anti-inflammatory and now recognized as owning regenerative capacities.

Whereas vitamin E acts as an antioxidant, free radical scavenger, facilitate angiogenesis and epithelialization. Thus, Nano Bio Fusion gel could be tested as a palatal wound dressing aiming to enhance postoperative wound healing and wound re-epithelization.

Palatal Stent will be used in the control group which was previously used in several studies. The choice of the stent was to confirm that any observed effect will be due to the gel only as stent will be used in both groups. Follow up will be over month.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sara M. Abdelrehim; Phone Number: +20 1275602402; Email: sara.abdelrehim@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Sara M. Abdelrehim; Phone Number: +20 127560204; Email: sara.abdelrehim@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nano-biofusion gel gingival gel (NBF); Coverage of the free gingival graft area in the palate with stent	Drug: Nano-bio fusion gingival gel; 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; Other Names: NBF gingival gel
Active Comparator: stent; Coverage of the free gingival graft area in the palate	Device: stent; Applied as a palatal stent for palatal wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Questionnaire	Day 30
Post-operative Pain Assessment	Visual Analogue Scale (VAS) will be used to evaluate pain with score staring from 0 (minimal pain) to 10(maximum pain)	14 days
Post-operative Pain Assessment	Number of analgesics consumption will be recorded by the patient	7 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Sara M. Abdelrehim, Bachelor, Cairo University, faculty of dentistry; Study Director: Weam El-Battawy, PHD, Cairo University, faculty of dentistry

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stent; Nano-Biofusion gel; Palatal Wound
• Other Study ID Numbers: 8422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No