NCT04758702|CompletedPhase 1DMC
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Sponsor study identifier
interventional
30
1 country
1
Study Start
February 24, 2021
Actual (reported)Primary Completion
May 25, 2023
Actual (reported)Study Completion
May 25, 2023
Actual (reported)A Randomized, Three Parallel Arms Clinical Trial to evaluate s the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 25, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2021
Actual (reported)February 17, 2021
Actual (reported)February 24, 2021
Actual (reported)May 25, 2023
Actual (reported)May 25, 2023
Actual (reported)The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
5 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
10 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
14 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
21 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
5 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
10 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
14 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
21 days
L-PRF membranes will be placed on the palatal donor site to help stabilizing the blood clot and release of growth factors that help in deceasing the discomfort wound healing.
H-PRF membranes will be placed on the palatal donor site to help stabilizing the blood clot and release of growth factors that help in deceasing the discomfort wound healing.
Leucocyte-Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly. Patient's own blood is centrifuged using (Intra-spin) FDA approved centrifuge on 45 degrees angle on 2700 rpm for 12 minutes.
Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly.Horizontally centrifuged platelet rich fibrin using (Bio-prf) centrifuge on 700 g force for 8 minutes. On a horizontal centrifugation, the cells separate much more efficiently throughout the entire membrane. This leads to better layer separation and also favors cells that are evenly distributed throughout the PRF clot.
University of Kentucky
Lexington, Kentucky, 40536, United States
Mohanad Al-Sabbagh, DDS, MS
University of Kentucky
30 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2021
First Posted
February 17, 2021
Study Start
February 24, 2021
Actual (reported)A surgical stent will be delivered to cover the surgical site and apply pressure on the wound site.
An essix surgical stent will be obtained using a high vacuum suction and used to protect the denuded donor site after suturing the wound. (Biostar® Scan/Biostar®V) will be used to make the stent.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 25, 2023
Actual (reported)Study Completion
May 25, 2023
Actual (reported)Last Updated
May 31, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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