Clinical trial NCT05442359: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Free Gingival Graft
Keywords: Nano-Biofusion gel
Stent
Palatal Wound
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound healing
timeFrame: Change in healing from baseline up to 4 weeks
Secondary outcomes:
measure: Post-operative Pain Assessment
timeFrame: 14 days
measure: Post-operative Pain Assessment
timeFrame: 7 days
measure: Patient Satisfaction
timeFrame: Day 30
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University, faculty of dentistry
name: Sara M. Abdelrehim, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University, faculty of dentistry
name: Weam El-Battawy, PHD
role: STUDY_DIRECTOR
References: