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

Free Gingival Graft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442359
• Other study ID #: 8422
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: Sara M. Abdelrehim
• Phone: 1275602402
• Email: sara.abdelrehim[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Free Gingival Graft

Intervention

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

Device:
• stent
Applied as a palatal stent for palatal wound

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Post-operative Pain Assessment	Number of analgesics consumption will be recorded by the patient	7 days
Secondary	Patient Satisfaction	Questionnaire	Day 30