Effect of Melatonin on Palatal Wound Healing (Randomized Controlled Clinical Trial)

Study Overview
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Brief Summary
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The aim of the study is to assess the effect of topical melatonin loaded gelatin sponge on donor palatal site healing, after palatal graft harvesting.

Detailed Description
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Autogenous soft tissue grafts can be considered the gold standard treatment for many muco-gingival problems. The most common site for harvesting soft tissue grafts is the palate. Many harvesting techniques have emerged, but the epithelialized graft harvesting technique is one of the most reliable and effective techniques as it imparts the superficial section of the connective tissue which contains the highest amount of lamina propria. Unfortunately, it leaves an open palatal wound healed by secondary intention, increasing pain and post-operative morbidity. In order to overcome these inadequacies investigators will cover the donor site with melatonin loaded gelatin sponge and evaluate its effect on the healing process.

Official Title
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Effect of Topically Applied Melatonin (N-ACETYL-5-METHOXY TRYPTAMINE) Loaded Gelatin Sponge on Palatal Wound Healing (Randomized Controlled Clinical Trial)

Conditions
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Wound Heal

Intervention / Treatment
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* Drug: Melatonin
* Drug: Carbopol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients who have at least one site of natural dentition or dental implants that need to be treated by free palatal graft surgery for indications including progressive recession, planned prosthodontics, presence of a mucogingival deformity, or a lack of keratinized gingiva. Patients who have at least 4 mm thickness of palatal mucosa (at donor site) Exclusion Criteria: History of smoking. Patients who have any known disease that interfere with periodontal surgery. Patients who have any dermal or autoimmune diseases. Patients who have any previous adverse reactions to the products (or similar products) used in this study. Pregnant and lactating women. Patients who have a palatal infection.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin group<br>Melatonin loaded Carbopol hydrogel will be synthesized as follows: 1 gm of Carbopol will be dissolved in 100 ml deionized water while stirring at 600 rpm for 25°C. Melatonin (3gm) will be dissolved in 1 ml ethanol and added to the formed gel while stirring at 600 rpm at 25 °C. The pH will be adjusted to 7.4 using triethanolamine until a gel is formed and it will be loaded on gelatin sponge and will be applied to the donor site. | Drug: Melatonin<br>* The donor site will be dressed with melatonin loaded gelatin sponge<br>* Other names: N-ACETYL-5-METHOXY TRYPTAMINE;|
| Placebo Comparator: Placebo group<br>•Topical placebo carbopol gel will be prepared as follows: 1 gm of Carbopol will be dissolved in 100ml deionized water while stirring at 600 rpm for 25°C. The pH will be adjusted to 7.4 using triethanolamine until a gel is formed | Drug: Carbopol<br>* The donor site will be dressed with carbopol loaded gelatin sponge (placebo).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| palatal wound healing | Standardized clinical photographs of the palatal surgical sites will be taken and will be imported into a software program (ImageJ 1.49v) and wound areas will be calculated by computerized planimetry (Difference in remaining wound area [mm2]) | Up to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain | by visual analogue scale Patients will be asked to grade the severity of their symptoms on VAS that ranges from (0-100 mm) | Up 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gelatin sponge, melatonin