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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Palate; Wound

Intervention / Treatment
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* Drug: GeliO3
* Drug: Gingi gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozone Gel<br>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<br>* Anti-inflammatory Gel which has a beneficial role on wound healing<br>|
| Experimental: Hyaluronic Acid 0.2%<br>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<br>* Anti-inflammatory Gel which has a beneficial role on wound healing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Wound Size | Wound size decrease/closure | 42 days |