Clinical trial NCT04348279: Propylene Mesh VS Standard Customized Palatal Stent as Protective Mechanical Barrier
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Randomized Controlled Trial, Human Study
Keywords: palatal wound, propylene mesh, palatal protection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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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Primary outcomes:
measure: Bleeding intensity
timeFrame: 14 days
measure: Bleeding duration
timeFrame: 14 days
measure: Pain level: VAS
timeFrame: 14 days
measure: pain duration
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
citation: 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.