Lack of Keratinized GingivaPhase 1NCT04758702
The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing.
A Phase 1 study testing L-PRF (Leucocyte- platelet rich fibrin), H-PRF (Horizontal -platelet rich fibrin) and Surgical stent in people with Lack of Keratinized Gingiva, run by Abdo Y Ismail at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lack of Keratinized Gingiva
- What is being tested?
- L-PRF (Leucocyte- platelet rich fibrin), H-PRF (Horizontal -platelet rich fibrin) and Surgical stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 25 May 2023
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing: A Randomized, Three Parallel Arms Clinical Trial.
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.
Read the detailed description
A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site by comparing the percentage of re-epithelization of the palatal donor site at 5, 10, 14 and 21 days using a standardized intraoral palatal photo.
The secondary objective is to compare the post op discomfort between the three groups during the healing period daily for 2 weeks using the Visual Analogue Scale (VAS) and Analgesic consumption.
All subjects from the University of Kentucky College of Dentistry clinics. Subjects that are coming increasing the width of keratinized tissue or for the treatment of gingival recession, and match the inclusion criteria will be told about the research and offered the opportunity to participate.
- Conditions
- Lack of Keratinized Gingiva
- Being tested
- L-PRF (Leucocyte- platelet rich fibrin), H-PRF (Horizontal -platelet rich fibrin), Surgical stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRF (Leucocyte- platelet rich fibrin)Biological
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.
H-PRF (Horizontal -platelet rich fibrin)Biological
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.
Surgical stentDevice
Also called Essix retainer
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.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | 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. Receives: Biological: L-PRF (Leucocyte- platelet rich fibrin) |
| GROUP 2 | Experimental | 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. Receives: Biological: H-PRF (Horizontal -platelet rich fibrin) |
| GROUP 3 | Experimental | A surgical stent will be delivered to cover the surgical site and apply pressure on the wound site. Receives: Device: Surgical stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.
Measured: 5 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.
Measured: 10 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.
Measured: 14 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
The secondary outcome is to compare the post-operative discomfort between the three groups during the healing period using the Visual Analogue Scale and Analgesic consumption. The visual analog scale is a validated, subjective measure for acute and chronic pain; with (0) indicates no pain and (10) indicates worst pain possible. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain", which is the (0) and "worst pain possible", which is the (10). Also, the patient will write down his/her analgesic consumption, including the frequency and the amount used.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start24 Feb 2021
- Primary completion25 May 2023
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lack of Keratinized GingivaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdo Y Ismail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdo Y Ismail, University of Kentucky
- Investigators
- Mohanad Al-Sabbagh, DDS, MS, Study chair, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758702
- Sponsor's protocol ID
- 63364
- Status last verified
- May 2023
- First submitted
- 8 Feb 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Impact of L-PRF, H-PRF or the Use of Surgical Stent on Palatal Donor Site Healing: A Randomized, Three Parallel Arms Clinical Trial.
- ClinicalTrials.gov ID
- NCT04758702
- Acronym / sponsor ID
- 63364
- Conditions
- Lack of Keratinized Gingiva
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Abdo Y IsmailUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 17 Feb 2021 (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.
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.
Detailed description
A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of L-PRF vs H-PRF vs Palatal stent on the healing of the donor palatal site by comparing the percentage of re-epithelization of the palatal donor site at 5, 10, 14 and 21 days using a standardized intraoral palatal photo.
The secondary objective is to compare the post op discomfort between the three groups during the healing period daily for 2 weeks using the Visual Analogue Scale (VAS) and Analgesic consumption.
All subjects from the University of Kentucky College of Dentistry clinics. Subjects that are coming increasing the width of keratinized tissue or for the treatment of gingival recession, and match the inclusion criteria will be told about the research and offered the opportunity to participate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Biological: L-PRF (Leucocyte- platelet rich fibrin)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. |
| GROUP 2 | Experimental | Biological: H-PRF (Horizontal -platelet rich fibrin)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. |
| GROUP 3 | Experimental | Device: Surgical stentA surgical stent will be delivered to cover the surgical site and apply pressure on the wound site. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| L-PRF (Leucocyte- platelet rich fibrin)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. | Biological | GROUP 1 |
| H-PRF (Horizontal -platelet rich fibrin)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. | Biological | GROUP 2 |
| Surgical stentAlso: Essix retainerAn 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. | Device | GROUP 3 |
Primary outcome
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time frame: 5 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time frame: 10 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time frame: 14 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time frame: 21 days
The primary outcome is to asses the percentage of re-epithelization of the palatal donor site and assess primary wound healing.
4 secondary outcomes
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time frame: 5 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time frame: 10 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time frame: 14 days
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing.
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
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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.
Mohanad Al-Sabbagh, DDS, MS study chair
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-PRF (Leucocyte- platelet rich fibrin), H-PRF (Horizontal -platelet rich fibrin) and Surgical stent in people with Lack of Keratinized Gingiva, run by Abdo Y Ismail at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 31 May 2023. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Clinical Impact of L-PRF, H-PRF, or the Use of a Surgical Stent on Palatal Donor Site Healing. (time frame: 5 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?
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 31 May 2023.