The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2021
CompletedFirst Posted
Study publicly available on registry
February 17, 2021
CompletedStudy Start
First participant enrolled
February 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2023
CompletedMay 31, 2023
May 1, 2023
2.2 years
February 8, 2021
May 28, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (4)
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
Study Arms (3)
GROUP 1
EXPERIMENTALL-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.
GROUP 2
EXPERIMENTALH-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.
GROUP 3
EXPERIMENTALA surgical stent will be delivered to cover the surgical site and apply pressure on the wound site.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Subjects between 18-65 years of age.
- Subjects need FGG or de-epithelialized Connective tissue graft
- Good oral hygiene (Plaque and bleeding indexes \<20%).
- Subjects can withstand alginate impression or wear a retainer.
- No other surgery or need for analgesics at the same site.
You may not qualify if:
- Subjects with any systemic disorders that might compromise wound healing (Uncontrolled diabetes mellitus, rheumatoid arthritis, osteoporosis, chemotherapy/radiotherapy and immunological disorders).
- Smokers
- Patients not maintaining oral hygiene (plaque score \>20%)
- Pregnant or breastfeeding females.
- Inability to provide informed consent.
- Grafts thickness more than 2mm will be excluded from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abdo Y Ismaillead
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40536, United States
Study Officials
- STUDY CHAIR
Mohanad Al-Sabbagh, DDS, MS
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Post-graduate Periodontics Resident
Study Record Dates
First Submitted
February 8, 2021
First Posted
February 17, 2021
Study Start
February 24, 2021
Primary Completion
May 25, 2023
Study Completion
May 25, 2023
Last Updated
May 31, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share