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

Primary Purpose

Free Gingival Graft

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Nano-bio fusion gingival gel
stent
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Free Gingival Graft focused on measuring Nano-Biofusion gel, Stent, Palatal Wound

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nano-biofusion gel gingival gel (NBF)

stent

Arm Description

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

Coverage of the free gingival graft area in the palate

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Post-operative Pain Assessment
Number of analgesics consumption will be recorded by the patient
Patient Satisfaction
Questionnaire

Full Information

First Posted
June 28, 2022
Last Updated
August 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05442359
Brief Title
Effect of Nano-Bio Fusion Gel on Palatal Wound Healing After Free Gingival Graft Harvest.
Official Title
The Effect of Nano-Bio Fusion Gingival Gel Versus Natural Healing on the Palatal Wound Healing After Harvesting Free Gingival Graft.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Free Gingival Graft
Keywords
Nano-Biofusion gel, Stent, Palatal Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nano-biofusion gel gingival gel (NBF)
Arm Type
Experimental
Arm Description
Coverage of the free gingival graft area in the palate with stent
Arm Title
stent
Arm Type
Active Comparator
Arm Description
Coverage of the free gingival graft area in the palate
Intervention Type
Drug
Intervention Name(s)
Nano-bio fusion gingival gel
Other Intervention Name(s)
NBF gingival gel
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
stent
Intervention Description
Applied as a palatal stent for palatal wound
Primary Outcome Measure Information:
Title
Wound healing
Description
Assessment of healing using the healing index scale by Landry with scale starting from (1 for very poor healing and 5 excellent healing)
Time Frame
Change in healing from baseline up to 4 weeks
Secondary Outcome Measure Information:
Title
Post-operative Pain Assessment
Description
Visual Analogue Scale (VAS) will be used to evaluate pain with score staring from 0 (minimal pain) to 10(maximum pain)
Time Frame
14 days
Title
Post-operative Pain Assessment
Description
Number of analgesics consumption will be recorded by the patient
Time Frame
7 days
Title
Patient Satisfaction
Description
Questionnaire
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara M. Abdelrehim
Phone
1275602402
Ext
+20
Email
sara.abdelrehim@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara M. Abdelrehim, Bachelor
Organizational Affiliation
Cairo University, faculty of dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weam El-Battawy, PHD
Organizational Affiliation
Cairo University, faculty of dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara M. Abdelrehim
Phone
127560204
Ext
+20
Email
sara.abdelrehim@dentistry.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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