NCT05690100

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

10 months

First QC Date

December 26, 2022

Last Update Submit

January 22, 2023

Conditions

Palate; Wound

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Color Match

    42 days

  • Wound Size

    42 days

Study Arms (2)

Ozone Gel

EXPERIMENTAL

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

Hyaluronic Acid 0.2%

EXPERIMENTAL

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

Interventions

GeliO3DRUG

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

Ozone Gel
Gingi gelDRUG

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

Hyaluronic Acid 0.2%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mucogingival defects scheduled for free gingival graft
  • Systemically healthy

You may not qualify if:

  • Smokers
  • Occlusal trauma at site of graft
  • Pregnancy and lactation
  • Patients allergic to the used agents
  • Severe gagging reflex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 28914592BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Ahmed M barbari

    Cairo University

    STUDY DIRECTOR

  • Dalia M Ghalwash

    Cairo University

    STUDY CHAIR

  • Nesma M Shemais

    Cairo University

    STUDY CHAIR

  • Hisham Ahmed

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisham T Ahmed

CONTACT

+201119993768Hisham.mahmoud@dentistry.cu.edu.eg

Nesma M Shemais

CONTACT

nesma.shemais@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Principal Investigator

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 19, 2023

Study Start

January 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01