Evaluation of the Use of Ozone Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing .

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05690100
Collaborator
(none)
56
2
11

Study Details

Study Description

Brief Summary

To compare the effect of Ozone Gel versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction after free gingival graft harvesting.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

To compare the effect of Ozone Gel versus Hyaluronic acid gel 0.2% applied to palatal donor site in post-operative pain reduction , Color match , Wound size closure after free gingival graft harvesting.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of the Use of Ozone Gel Versus Hyaluronic Acid Gel on Palatal Wound After Free Gingival Graft Harvesting: A Randomized Controlled Clinical Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ozone Gel

Ozone is a potent oxidant with marked antimicrobial activity and the potential to act as a metabolic and host immune modulator.The routes of ozone administration are topical and regional for both gaseous and aqueous forms .Ozone gel is contains ozonated extra virgin olive oil and Arnica montana extract, containing essential fatty acids Ozone gel was claimed to have analgesic (Tasxdemir et al,2016) and anti-inflammatory effect its high content of essential fatty acids and the effect of ozone, natural extra virgin olive oil (I. Lezcano,et al.2000). Ozone gel has a beneficial role in wound healing, Its wound healing properties may be due to enhancing blood circulation and immune response.(M.colombo et,al 2019), Generic name : GeliO3 Dosage form : Gel Frequency/Duration : Once on this interval : 0,3,7,14

Drug: GeliO3
Anti-inflammatory Gel which has a beneficial role on wound healing

Experimental: Hyaluronic Acid 0.2%

HA was Known for hygroscopicity that allows it to maintain conformational stiffness and to retain water.(Yıldırım et al., 2017b) .Another major feature is viscoelasticity that provides stability and elasticity to tissues and delays penetration of viruses and bacteria (Finn, Schow and Schneiderman, 1992) . In periodontology, HA has been advocated as monotherapy(Hammad et al., 2011) or as an adjunct to non-surgical and/or surgical (Fawzy El-Sayed et al., 2012) periodontal treatment to reduce inflammation and promote wound healing. HA gel was used in two different concentrations 0.2% and 0.8% versus negative control in the management of post-operative pain after FGG surgery and it was found effective with more superior results for the 0.2% concentration (Yıldırım et al., 2017b). Generic name : GingiGel Dosage form : Gel Frequency/Duration : Once on this interval : 0,3,7,14

Drug: Gingi gel
Anti-inflammatory Gel which has a beneficial role on wound healing

Outcome Measures

Primary Outcome Measures

  1. Post Operative Pain [14 days]

    Post operative pain measured directly through VAS score with 0 means no pain and 10 means the maximum pain or indirectly by analgesics consumption by the patient

Secondary Outcome Measures

  1. Color Match [42 days]

    the color of the palatal mucosa will be assessed by comparing it with that of the adjacent and opposite side by using the objective VAS (VAS score 0-10) represented by a continuous line, by a clinician blinded to the treatment group assignment. A score of 0 indicates no color match, and a score of 10 indicates excellent color match with the adjacent tissues.

  2. Wound Size [42 days]

    Wound size decrease/closure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients with mucogingival defects scheduled for free gingival graft

  • Systemically healthy

Exclusion Criteria:
  • Smokers

  • Occlusal trauma at site of graft

  • Pregnancy and lactation

  • Patients allergic to the used agents

  • Severe gagging reflex

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Ahmed M barbari, Cairo University
  • Study Chair: Dalia M Ghalwash, Cairo University
  • Study Chair: Nesma M Shemais, Cairo University
  • Principal Investigator: Hisham Ahmed, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hisham Tarek Mahmoud Ahmed, The Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05690100
Other Study ID Numbers:
  • OZVHA
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023