Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting

Study Overview
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Brief Summary
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clinical comparison between alvogyl and gelatin sponge when used to protect the denuded area of the palatal donor site after free gingival graft in means of reducing pain and healing.

Official Title
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Clinical Comparison of Alveogyl and Gelatin Sponge in the Management of Pain After Epithelialized Free Gingival Graft Harvesting: A Randomized Clinical Trial

Conditions
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Pain, Procedural

Intervention / Treatment
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* Drug: Gelatin Sponge Sheet
* Drug: Alvogyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for different periodontal and peri-implant plastic surgeries requiring palatal mucosal graft harvesting Systemically healthy Exclusion Criteria: Severe gagging reflex Smokers Occlusal trauma at site of graft Pregnancy Psychiatric disorder Patients allergic to the used agents
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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>Gelatin Sponge Sheet is a heamostatic agent act as a mechanical barrier to protect the palatal donor site | Drug: Gelatin Sponge Sheet<br>* sheets act as a mechanical barrier used to protect the denuded area of the palatal donor site<br>* Other names: gel foam;|
| Experimental: intervention group<br>alvogyl in a paste form with analgesic action to protect the palatal donor site and help to relief pain | Drug: Alvogyl<br>* paste form with analgesic action to protect the palatal donor site and help to relief pain<br>* Other names: Alveogyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | recorded by the pain trough a Visual Analogue scale score (between 0 and 10. 0: no pain, 1: minimal pain,10: severe pain) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing | healing of the palatal mucosa using H2O2 Test this test is based on the principle that if the epithelium is discontinuous, then H2O2 diffuses into the CT, the enzyme catalase acts on H2O2to release water and oxygen. This is shown clinically by the production of bubbles on the wound. The area to be evaluated is then dried, and 3% H2O2 is sprinkled on the wound with a syringe, waiting for the appearance of bubbles, which will suggest that the surgical site is not completely epithelialized. Complete healing will be recorded as a dichotomous variable (yes/no). | 4 weeks | 
| bleeding | Questionaire, Binary (yes or no). | 2 weeks | 
| analgesic consumption | questionaure, Numerical, Amount of analgesics daily consumption | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alveogyl, gelatin sponge, free gingival graft, palate, pain