Clinical Comparison of Application of Curcumin Gel in Pain Management After Free Gingival Graft Harvesting

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of using 2% curcumin gel versus gelatin sponge when applied to palatal donor site in pain management and wound healing after free gingival graft harvesting.

Official Title
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Clinical Comparison of Topical Application of Curcumin Gel Versus Gelatin Sponge in Pain Management and Wound Healing After Free Gingival Graft Harvesting: a Randomized Controlled Clinical Trial

Conditions
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Palate; Wound

Intervention / Treatment
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* Other: curcumin gel 2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systematically healthy patient (American Society of Anesthesiology class I and II). Male or female Patients with mucogingival defects scheduled for free gingival graft. Patients with good oral hygiene. Exclusion Criteria: Patients with any uncontrolled local or systemic disease where periodontal plastic surgery might be contraindicated. History of recent periodontal surgery at the donor site. Smokers. Pregnancy and lactation. Patients allergic to the used agents, Severe gagging reflex. Inability or unwillingness to provide informed consent.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curcumin gel<br>the denuded palatal area will be superficially covered with a continuous thin layer of curcumin gel 2% one time immediately after the surgery (curcumin gel will be prepared in 2% concentration on a carbapol base)according to (Bhatia et al., 2014) | Other: curcumin gel 2%<br>* curcumin gel 2%<br>|
| Active Comparator: gelatine sponge<br>absorbable gelatin sponge will be cut to the palatal wound size and applied. Following manual compression of the wound area, both agents will be secured in place using compressive palatal sling sutures. commercial name (CUTANPLAST) | Other: curcumin gel 2%<br>* curcumin gel 2%<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 by visual analouge scale from 0 (no pain) to 10 (highest pain value) | one week post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue healing of the palatal wound | Soft tissue healing of the palatal wound measured by Modified Landry's wound healing score from 1 indicates poorest healing to 5 indicates excellent healing | up to three weeks post-operative | 
| Re-epithelization of the palatal wound | Re-epithelization of the palatal wound using H2O2 test | up to three weeks post-operative |