Platelets Rich Fibrin, Palatal Donor TissuePhase 4NCT02521467
Adjunctive Role of PRF After Free Gingival Graft Harvesting - Case Series
A Phase 4 study testing Platelets Rich Fibrin in healing of palatal donor tissue in people with Platelets Rich Fibrin, Palatal Donor Tissue, run by Ain Shams University.
Trial summary
Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Platelets Rich Fibrin, Palatal Donor Tissue
- What is being tested?
- Platelets Rich Fibrin in healing of palatal donor tissue
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2015
- Phase
- Phase 4
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation
Who cannot join
- High arched palate, medically compromised
About this study
Official title: Adjunctive Role of Platelets Rich Fibrin in Palatal Wound Healing After Free Gingival Graft Harvesting - Case Series
Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious approach to protect the raw wound area of a palatal donor site to reduce healing time and patient discomfort.
Read the detailed description
Introduction:
Free gingival grafts are one of the common treatment modalities used to increase the zone of keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The palatal donor sites had many complications as pain, discomfort and healing by secondary intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors fasten the healing and decrease the pain.
Materials and methods:
Ten patients requiring augmentation of KT participated in this case series. The palatal donor sites of 7 of these patients were covered with PRF membranes with a new suturing technique without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed during one week in the group with PRF.
- Being tested
- Platelets Rich Fibrin in healing of palatal donor tissue, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelets Rich Fibrin in healing of palatal donor tissueBiological
Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors as PDGF, IGF, TGF which had a role in hemostasis fasten the healing and decrease the pain.
PlaceboOther
Also called Palatal stent
the other group is a control group, had no biologic in the palatal wound, only palatal stent
| Study group | Role | What they receive |
|---|---|---|
| PRF | Active comparator | Platelets Rich Fibrin Receives: Biological: Platelets Rich Fibrin in healing of palatal donor tissue |
| palatal stent | Placebo comparator | Palatal stent Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment by Visual Analog Scale (VAS)
VAS ranged from 0 (no pain ) to 10 (severe pain)
Measured: 1 week postoperative
Clinical healing of the palate
color match, consistency and thickness of palate (Composite measure)
Measured: 2 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJan 2014
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelets Rich Fibrin, Palatal Donor TissueStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Adel Salah Khattab, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521467
- Sponsor's protocol ID
- Doaa Adel
- Status last verified
- Aug 2015
- First submitted
- 28 Jul 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Role of Platelets Rich Fibrin in Palatal Wound Healing After Free Gingival Graft Harvesting - Case Series
- ClinicalTrials.gov ID
- NCT02521467
- Acronym / sponsor ID
- Doaa Adel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
Free gingival grafts are important to increase zone of attached gingiva and root coverage. This case series reveals role of platelet-rich fibrin (PRF) as adjunctive therapy in palatal wound healing. The superior healing observed at the PRF membrane sites supports its use in accelerating soft-tissue healing. PRF membrane as a palatal bandage is an efficacious approach to protect the raw wound area of a palatal donor site to reduce healing time and patient discomfort.
Detailed description
Introduction:
Free gingival grafts are one of the common treatment modalities used to increase the zone of keratinized tissue (KT) around implants or prior to ridge augmentation and root coverage. The palatal donor sites had many complications as pain, discomfort and healing by secondary intention. Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors fasten the healing and decrease the pain.
Materials and methods:
Ten patients requiring augmentation of KT participated in this case series. The palatal donor sites of 7 of these patients were covered with PRF membranes with a new suturing technique without palatal stent, the other 3 had palatal stent. Palatal tissue will examined clinically after 3, 7, 10 and 14 days. Considerably very fast healing with 0 pain score was observed during one week in the group with PRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF | Active comparator | Biological: Platelets Rich Fibrin in healing of palatal donor tissuePlatelets Rich Fibrin |
| palatal stent | Placebo comparator | Other: PlaceboPalatal stent |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Systemic free, Good oral hygiene and insufficient attached gingiva prior to ridge augmentation
Key exclusion criteria (1 listed)
- High arched palate, medically compromised
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 |
|---|---|---|
| Platelets Rich Fibrin in healing of palatal donor tissuePlatelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors as PDGF, IGF, TGF which had a role in hemostasis fasten the healing and decrease the pain. | Biological | PRF |
| PlaceboAlso: Palatal stentthe other group is a control group, had no biologic in the palatal wound, only palatal stent | Other | palatal stent |
Primary outcome
Pain Assessment by Visual Analog Scale (VAS)
Time frame: 1 week postoperative
VAS ranged from 0 (no pain ) to 10 (severe pain)
Clinical healing of the palate
Time frame: 2 weeks postoperative
color match, consistency and thickness of palate (Composite measure)
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 13 Aug 2015.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelets Rich Fibrin in healing of palatal donor tissue in people with Platelets Rich Fibrin, Palatal Donor Tissue, run by Ain Shams University.
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 1 inclusion and 1 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain Assessment by Visual Analog Scale (VAS) (time frame: 1 week postoperative). The study lists 2 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 13 Aug 2015.