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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin group | Experimental | 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. |
|
| Placebo group | Placebo Comparator | •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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | The donor site will be dressed with melatonin loaded gelatin sponge |
|
| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salma Nabil, BDS | Contact | 01099076119 | 002 | Salma.Nabil.dent@alexu.edu.eg |
| Ahmed haggag, BDS | Contact | 01066292227 | 002 | ahmedhagag90@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| salma Nabil, BDS | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Recruiting | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| C006912 | carboxypolymethylene |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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This study will be double-blinded where the patients and the statistician will be unaware of the treatment assignment till the end of the trial.
| Carbopol | Drug | The donor site will be dressed with carbopol loaded gelatin sponge (placebo). |
|
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |