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

Palate; Wound Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05690100
• Other study ID #: OZVHA
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Cairo University
• Contact: Hisham T Ahmed
• Phone: +201119993768
• Email: Hisham.mahmoud[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Palate; Wound
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (1)

Yildirim S, Ozener HO, Dogan B, Kuru B. Effect of topically applied hyaluronic acid on pain and palatal epithelial wound healing: An examiner-masked, randomized, controlled clinical trial. J Periodontol. 2018 Jan;89(1):36-45. doi: 10.1902/jop.2017.170105. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Pain	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	14 days
Secondary	Color Match	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.	42 days
Secondary	Wound Size	Wound size decrease/closure	42 days