Propylene Mesh VS Standard Customized Palatal Stent as Protective Mechanical Barrier

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)

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.

Study Overview

• Status: Unknown
• Conditions: Randomized Controlled Trial, Human Study
• Intervention / Treatment: Device: propylene mesh

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12511
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Yussif N, Wagih R, Selim K. Propylene mesh versus acrylic resin stent for palatal wound protection following free gingival graft harvesting: a short-term pilot randomized clinical trial. BMC Oral Health. 2021 Apr 26;21(1):208. doi: 10.1186/s12903-021-01541-z.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Anticipated): May 8, 2020
• Study Completion (Anticipated): May 20, 2020

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: palatal wound, propylene mesh, palatal protection
• Other Study ID Numbers: 1006 (Institut Pasteur)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: if the polypropylene mesh could be used as a palatal protector for the palatal wound following harvesting of a soft tissue graft

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No