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

NCT ID: NCT05442359

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-07-01

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.

Conditions

Free Gingival Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nano-biofusion gel gingival gel (NBF)

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

Group Type: EXPERIMENTAL

Nano-bio fusion gingival gel

Intervention Type: DRUG

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

stent

Coverage of the free gingival graft area in the palate

Group Type: ACTIVE_COMPARATOR

stent

Intervention Type: DEVICE

Applied as a palatal stent for palatal wound

Interventions

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

Intervention Type: DRUG

stent

Applied as a palatal stent for palatal wound

Intervention Type: DEVICE

Other Intervention Names

NBF gingival gel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mohamed Mahmoud Abdelrehim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara M. Abdelrehim, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Cairo University, faculty of dentistry

Weam El-Battawy, PHD

Role: STUDY_DIRECTOR

Cairo University, faculty of dentistry

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

References

Abdelrehim SMM, Elbattawy WA, Ashour OAM. The effect of nano-bio fusion gingival gel versus palatal stent on the palatal wound healing after harvesting free gingival graft: a randomized controlled clinical trial. BDJ Open. 2025 Aug 11;11(1):73. doi: 10.1038/s41405-025-00360-6.

Reference Type: DERIVED

PMID: 40790022 (View on PubMed)

Other Identifiers

8422

Identifier Type: -

Identifier Source: org_study_id