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Completed

NCT Number: NCT05442359

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

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.

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Key information

Conditions

Free Gingival Graft

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nano-bio fusion gingival gel

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

Other names: NBF gingival gel

stent

Device

Applied as a palatal stent for palatal wound

Primary outcomes

  1. Wound healing

    Time frame: Change in healing from baseline up to 4 weeks

    Assessment of healing using the healing index scale by Landry with scale starting from (1 for very poor healing and 5 excellent healing)

Secondary outcomes

  1. Post-operative Pain Assessment

    Time frame: 14 days

    Visual Analogue Scale (VAS) will be used to evaluate pain with score staring from 0 (minimal pain) to 10(maximum pain)

  2. Post-operative Pain Assessment

    Time frame: 7 days

    Number of analgesics consumption will be recorded by the patient

  3. Patient Satisfaction

    Time frame: Day 30

    Questionnaire

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2022
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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