Propylene Mesh VS Standard Customized Palatal Stent as Protective Mechanical Barrier

Study Overview
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Brief Summary
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protection of the palatal wound is an essential step following harvesting a palatal soft tissue graft. During the last decades, several materials were used to avoid protect against the post-operative problems as bleeding, pain and possible infections. The aim of this randomized clinical trial was to assess the usage of polypropylene mesh, compared to the conventional custom-made acrylic stent for efficacy in protection of the palatal wound and reducing the bleeding tendency and post-operative pain. propylene mesh is a promising material for protection of the palatal wound due to its light weight, limited bacterial wicking, tissue compatible properties, however, the custom made acrylic palatal stent provides a more precise mechanical . More studies are required to deeply assess the benefits of this material in the periodontal plastic surgeries.

Detailed Description
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Background: protection of the palatal wound is an essential step following harvesting a palatal soft tissue graft. During the last decades, several materials were used to avoid protect against the post-operative problems as bleeding, pain and possible infections. The aim of this randomized clinical trial was to assess the usage of polypropylene mesh, compared to the conventional custom-made acrylic stent for efficacy in protection of the palatal wound and reducing the bleeding tendency and post-operative pain. Patients and methods: A single blinded, parallel group randomized controlled trial took place. Twenty sites were approved to be treated using soft tissue grafting technique with the need for a palatally harvested free graft. The palatal wounds were protected with propylene mesh and custom-made acrylic palatal sten. Participants were qualitatively assessed for bleeding duration, bleeding amount, pain duration, infection possibility, inflammation at 2, 4, 6, 8, 14 days post-operatively. The patient acceptance was also evaluated.

Official Title
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Propylene Mesh VS Standard Customized Palatal Stent as Protective Mechanical Barrier Following Harvesting of a Free Palatal Graft: A Short-term Pragmatic Randomized Clinical Trial (Part 1)

Conditions
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Randomized Controlled Trial, Human Study

Intervention / Treatment
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* Device: propylene mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:medically free, above 18 years old, non-smokers with healthy reduced periodontium (free of any active disease either gingivitis or periodontitis) - Exclusion Criteria:During selection, smokers, medically compromised, pregnant and lactating mothers, patients with gagging reflex, incompliant patients, presence of periodontal disease, presence of fixed orthodontic palatal appliance were excluded -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: custom made acrylic stent<br>the donor sites of the participants were covered with custom made acrylic stent | Device: propylene mesh<br>* propylene mesh as a palatal stent for palatal wound<br>|
| Experimental: propylene mesh<br>in the test group, the donor sites received propylene mesh. | Device: propylene mesh<br>* propylene mesh as a palatal stent for palatal wound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding intensity | Evaluation of the bleeding amount using VAS test (descriptive tool) | 14 days | 
| Bleeding duration | Evaluation of the duration of bleeding | 14 days | 
| Pain level: VAS | evaluation of the pain severity using VAS test (descriptive tool) | 14 days | 
| pain duration | evaluation of the pain duration | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palatal wound, propylene mesh, palatal protection