Propylene Mesh VS Standard Customized Palatal Stent as Protective Mechanical Barrier

Not Applicable

• Conditions: Randomized Controlled Trial, Human Study
• Interventions: Device: propylene mesh

• Registration Number: NCT04348279
• Lead Sponsor: Cairo University

Brief 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.

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 Timeline

• Study Start: 2018-04-05
• Status Verified: 2020-04
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Study First Posted: 2020-04-16
• Last Update Posted: 2020-04-16
• Primary Completion: 2020-05-08
• Study Completion: 2020-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
custom made acrylic stent	propylene mesh	the donor sites of the participants were covered with custom made acrylic stent
propylene mesh	propylene mesh	in the test group, the donor sites received propylene mesh.

Primary Outcome Measures

Name	Time	Method
pain duration	14 days	evaluation of the pain duration
Bleeding intensity	14 days	Evaluation of the bleeding amount using VAS test (descriptive tool)
Pain level: VAS	14 days	evaluation of the pain severity using VAS test (descriptive tool)
Bleeding duration	14 days	Evaluation of the duration of bleeding

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt