Palate; WoundNCT05690100
Evaluation of the Use of Ozone Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing .
A study testing GeliO3 and Gingi gel in people with Palate; Wound, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palate; Wound
- What is being tested?
- GeliO3 and Gingi gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mucogingival defects scheduled for free gingival graft
- Systemically healthy
Who cannot join
- Smokers
- Occlusal trauma at site of graft
- Pregnancy and lactation
- Patients allergic to the used agents
- Severe gagging reflex
Trial locations and contacts
No sites are listed yet.
Nesma M Shemais contact
About this study
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
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.
Read the 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.
- Conditions
- Palate; Wound
- Being tested
- GeliO3, Gingi gel
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeliO3Drug
Anti-inflammatory Gel which has a beneficial role on wound healing
Gingi gelDrug
Anti-inflammatory Gel which has a beneficial role on wound healing
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Gingi gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (2)
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.
Measured: 42 days
Wound Size
Wound size decrease/closure
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palate; WoundStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Tarek Mahmoud Ahmed, Cairo University
- Investigators
- Ahmed M barbari, Study director, Cairo UniversityDalia M Ghalwash, Study chair, Cairo UniversityNesma M Shemais, Study chair, Cairo UniversityHisham Ahmed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690100
- Sponsor's protocol ID
- OZVHA
- Status last verified
- Jan 2023
- First submitted
- 26 Dec 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28914592
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05690100
- Acronym / sponsor ID
- OZVHA
- Conditions
- Palate; Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone Gel | Experimental | Drug: GeliO3Ozone 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 |
| Hyaluronic Acid 0.2% | Experimental | Drug: Gingi gelHA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mucogingival defects scheduled for free gingival graft
- Systemically healthy
Key exclusion criteria (5 listed)
- Smokers
- Occlusal trauma at site of graft
- Pregnancy and lactation
- Patients allergic to the used agents
- Severe gagging reflex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GeliO3Anti-inflammatory Gel which has a beneficial role on wound healing | Drug | Ozone Gel |
| Gingi gelAnti-inflammatory Gel which has a beneficial role on wound healing | Drug | Hyaluronic Acid 0.2% |
Primary outcome
Post Operative Pain
Time frame: 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
2 secondary outcomes
Color Match
Time frame: 42 days
Wound Size
Time frame: 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 28914592Yildirim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nesma M Shemais contact
Ahmed M barbari study director
Cairo University
Dalia M Ghalwash study chair
Cairo University
Nesma M Shemais study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing GeliO3 and Gingi gel in people with Palate; Wound, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hisham T Ahmed (+201119993768, Hisham.mahmoud@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Pain (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.