Propylene Mesh VS Standard Customized Palatal Stent as Protective Mechanical Barrier

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04348279
Collaborator
(none)
20
1
2
25.5
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: propylene mesh
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Supportive Care
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)
Actual Study Start Date :
Apr 5, 2018
Anticipated Primary Completion Date :
May 8, 2020
Anticipated Study Completion Date :
May 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Bleeding intensity [14 days]

    Evaluation of the bleeding amount using VAS test (descriptive tool)

  2. Bleeding duration [14 days]

    Evaluation of the duration of bleeding

  3. Pain level: VAS [14 days]

    evaluation of the pain severity using VAS test (descriptive tool)

  4. pain duration [14 days]

    evaluation of the pain duration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry Cairo Egypt 12511

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
nermin mohammed ahmed yussif, PhD holder, Cairo University
ClinicalTrials.gov Identifier:
NCT04348279
Other Study ID Numbers:
  • 1006
First Posted:
Apr 16, 2020
Last Update Posted:
Apr 16, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by nermin mohammed ahmed yussif, PhD holder, Cairo University

Study Results

No Results Posted as of Apr 16, 2020