Clincosm LogoSign in Get a demo

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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05442359
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nano-bio fusion gingival gel
  • Device: Acrylic stent
 Phase 4

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.

Acrylic 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Nano-Bio Fusion Gingival Gel Versus Natural Healing on the Palatal Wound Healing After Harvesting Free Gingival Graft.
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nano-biofusion gel gingival gel (NBF)

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

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
Other Names:
  • NBF gingival gel

    		•
    Active Comparator: Acrylic stent

    Coverage of the free gingival graft area in the palate

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

    Outcome Measures

    Primary Outcome Measures

    1. Wound healing [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 Outcome Measures

    1. Post-operative Pain Assessment [7 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 [14 days]

      Number of analgesics consumption will be recorded by the patient

    3. Patient Satisfaction [Day 30]

      Questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Sara M. Abdelrehim, Bachelor, Cairo University, faculty of dentistry
    • Study Director: Weam El-Battawy, PHD, Cairo University, faculty of dentistry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Mohamed Mahmoud Abdelrehim, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05442359
    Other Study ID Numbers:
    • 8422
    First Posted:
    Jul 5, 2022
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Sara Mohamed Mahmoud Abdelrehim, Principal Investigator, Cairo University
    Nano-Biofusion gel
    Acrylic Stent
    Palatal Wound

    Study Results

    No Results Posted as of Jul 5, 2022