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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Free Gingival Graft

Intervention / Treatment
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* Drug: Nano-bio fusion gingival gel
* Device: stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Patient Satisfaction | Questionnaire | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nano-Biofusion gel, Stent, Palatal Wound