Propylene Mesh VS Standard Customized Palatal Stent as Protective Mechanical Barrier

Randomized Controlled Trial, Human Study Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04348279
• Other study ID #: 1006
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: May 20, 2020

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 20, 2020
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

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Related Conditions & MeSH terms

• Randomized Controlled Trial, Human Study

Intervention

Device:
• propylene mesh
propylene mesh as a palatal stent for palatal wound

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding intensity	Evaluation of the bleeding amount using VAS test (descriptive tool)	14 days
Primary	Bleeding duration	Evaluation of the duration of bleeding	14 days
Primary	Pain level: VAS	evaluation of the pain severity using VAS test (descriptive tool)	14 days
Primary	pain duration	evaluation of the pain duration	14 days