Randomized Controlled Trial, Human StudyNCT04348279
Propylene Mesh VS Standard Customized Palatal Stent as Protective Mechanical Barrier
A study testing propylene mesh in people with Randomized Controlled Trial, Human Study, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Randomized Controlled Trial, Human Study
- What is being tested?
- propylene mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2018to 20 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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
-
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Randomized Controlled Trial, Human Study
- Being tested
- propylene mesh
- Keywords
- palatal wound, propylene mesh, palatal protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propylene meshDevice
propylene mesh as a palatal stent for palatal wound
| Study group | Role | What they receive |
|---|---|---|
| custom made acrylic stent | Active comparator | the donor sites of the participants were covered with custom made acrylic stent Receives: Device: propylene mesh |
| propylene mesh | Experimental | in the test group, the donor sites received propylene mesh. Receives: Device: propylene mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding intensity
Evaluation of the bleeding amount using VAS test (descriptive tool)
Measured: 14 days
Bleeding duration
Evaluation of the duration of bleeding
Measured: 14 days
Pain level: VAS
evaluation of the pain severity using VAS test (descriptive tool)
Measured: 14 days
pain duration
evaluation of the pain duration
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start5 Apr 2018
- Primary completion8 May 2020 (estimated)
- Study completion20 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Randomized Controlled Trial, Human StudyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nermin mohammed ahmed yussif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348279
- Sponsor's protocol ID
- 1006
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: if the polypropylene mesh could be used as a palatal protector for the palatal wound following harvesting of a soft tissue graft
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.
PubMed 33902550
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04348279
- Acronym / sponsor ID
- 1006
- Conditions
- Randomized Controlled Trial, Human Study
- Keywords
- palatal wound, propylene mesh, palatal protection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 8 May 2020 (estimated)
- Study completion
- 20 May 2020 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| custom made acrylic stent | Active comparator | Device: propylene meshthe donor sites of the participants were covered with custom made acrylic stent |
| propylene mesh | Experimental | Device: propylene meshin the test group, the donor sites received propylene mesh. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propylene meshpropylene mesh as a palatal stent for palatal wound | Device | custom made acrylic stent, propylene mesh |
Primary outcome
Bleeding intensity
Time frame: 14 days
Evaluation of the bleeding amount using VAS test (descriptive tool)
Bleeding duration
Time frame: 14 days
Evaluation of the duration of bleeding
Pain level: VAS
Time frame: 14 days
evaluation of the pain severity using VAS test (descriptive tool)
pain duration
Time frame: 14 days
evaluation of the pain duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Derived from this study: PubMed 33902550Yussif 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.
- Individual participant dataSharing planned: No. if the polypropylene mesh could be used as a palatal protector for the palatal wound following harvesting of a soft tissue graft
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propylene mesh in people with Randomized Controlled Trial, Human Study, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding intensity (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04348279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020; AzTrials last refreshed its copy on 1 Nov 2026.