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

Phase 4

Completed

• Conditions: Free Gingival Graft
• Interventions: Drug: Nano-bio fusion gingival gel; Device: stent

• Registration Number: NCT05442359
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-30
• Study First Posted: 2022-07-05
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nano-biofusion gel gingival gel (NBF)	Nano-bio fusion gingival gel	Coverage of the free gingival graft area in the palate with stent
stent	stent	Coverage of the free gingival graft area in the palate

Primary Outcome Measures

Name	Time	Method
Wound healing	Change in healing from baseline up to 4 weeks	Assessment of healing using the healing index scale by Landry with scale starting from (1 for very poor healing and 5 excellent healing)

Secondary Outcome Measures

Name	Time	Method
Post-operative Pain Assessment	7 days	Number of analgesics consumption will be recorded by the patient
Patient Satisfaction	Day 30	Questionnaire

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt