PainNCT02797899
Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft
A study testing Platelet Rich Fibrin in people with Pain and Wound Healing, run by King Abdulaziz University.
Trial summary
Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and decrease pain scores. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Wound Healing
- What is being tested?
- Platelet Rich Fibrin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Oct 2015
- 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
Who may be able to join
- lack of keratinized tissue in the mandibular central incisor region
Who cannot join
- smoking
- uncontrolled systemic disease that might contraindicate periodontal surgery
- severe gag reflex preventing maxillary surgical procedure
- inability or unwillingness to provide informed consent
About this study
Official title: Effect of Platelet Rich Fibrin Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft
Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and decrease pain scores.
Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form. The palatal donor area were evaluated for complete wound healing records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.
Read the detailed description
Background: Despite a relatively painful surgical procedure, free gingival graft (FGG) is still commonly used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) after harvesting a FGG would improve soft tissue healing of donor sites and subsequently decrease pain scores.
Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Enrolled patients received periodontal examination, oral hygiene instructions and full-mouth debridement followed by standardized FGG of similar dimensions. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form to analyze pain scores including VAS, NRS-101, VRS-4 as well as three anxiety scales at base line. The palatal donor area were evaluated for complete wound healing based on the degree of color match, tissue texture, and contour of the surgical area compared to preoperative records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.
- Conditions
- Pain, Wound Healing
- Being tested
- Platelet Rich Fibrin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich FibrinDevice
Native growth factors
| Study group | Role | What they receive |
|---|---|---|
| Palatal donor site received PRF | Active comparator | Following profound anesthesia and harvesting free gingival graft from the palate, the graft was positioned to the recipient area. The donor area were cleaned with sterile saline and received platelet rich fibrin and periodontal pack as assigned randomly by a flip of coin during the screening visits. Receives: Device: Platelet Rich Fibrin |
| Palatal donor site NOT receiving PRF | Active comparator | Following profound anesthesia and harvesting free gingival graft from the palate, the graft was positioned to the recipient area. The donor area were cleaned with sterile saline and sutured followed by periodontal pack application. Receives: Device: Platelet Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Visual Analog scale (VAS)
a visual analog scale (VAS) consisting a 10-cm line with two extremes at either end. "no pain" and "pain that could not be more severe". Patients were asked to mark a point on the line that represent their level of perceived pain
Measured: 1, 2, 3, 4 and 8 weeks
Secondary outcomes (3)
Changes in contour of the surgical area
To check for wound healing; contour of the surgical area was examined and compared to preoperative records
Measured: 1, 2, 3, 4 and 8 weeks
Changes in degree of color match
To check for wound healing; degree of color match was examined and compared to preoperative records
Measured: 1, 2, 3, 4 and 8 weeks
Changes in tissue texture
To check for wound healing; tissue texture was examined and compared to preoperative records
Measured: 1, 2, 3, 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startSep 2013
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha A. Bahammam, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797899
- Sponsor's protocol ID
- 285/254/1434
- Status last verified
- Mar 2024
- First submitted
- 2 Jun 2016
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet Rich Fibrin Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft
- ClinicalTrials.gov ID
- NCT02797899
- Acronym / sponsor ID
- 285/254/1434
- Conditions
- Pain, Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Jun 2016 (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.
Background: Free gingival graft (FGG) is used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) would improve soft tissue healing of donor sites and decrease pain scores.
Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form. The palatal donor area were evaluated for complete wound healing records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.
Detailed description
Background: Despite a relatively painful surgical procedure, free gingival graft (FGG) is still commonly used to increase keratinized tissue dimensions. This prospective clinical trial was conducted aiming to determine whether the addition of an autologous platelet-rich fibrin (PRF) after harvesting a FGG would improve soft tissue healing of donor sites and subsequently decrease pain scores.
Methods: Twenty four patients were planned to receive FGG to augment keratinized tissue dimensions in the mandibular incisors area. Enrolled patients received periodontal examination, oral hygiene instructions and full-mouth debridement followed by standardized FGG of similar dimensions. Donor sites were assigned randomly to receive PRF or not by a flip of a coin during the screening visit. Patients were instructed to complete a pain study form to analyze pain scores including VAS, NRS-101, VRS-4 as well as three anxiety scales at base line. The palatal donor area were evaluated for complete wound healing based on the degree of color match, tissue texture, and contour of the surgical area compared to preoperative records. These data were assessed and recorded before surgery, and 1,2,3,4 and 8 weeks postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palatal donor site received PRF | Active comparator | Device: Platelet Rich FibrinFollowing profound anesthesia and harvesting free gingival graft from the palate, the graft was positioned to the recipient area. The donor area were cleaned with sterile saline and received platelet rich fibrin and periodontal pack as assigned randomly by a flip of coin during the screening visits. |
| Palatal donor site NOT receiving PRF | Active comparator | Device: Platelet Rich FibrinFollowing profound anesthesia and harvesting free gingival graft from the palate, the graft was positioned to the recipient area. The donor area were cleaned with sterile saline and sutured followed by periodontal pack application. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- lack of keratinized tissue in the mandibular central incisor region
Key exclusion criteria (4 listed)
- smoking
- uncontrolled systemic disease that might contraindicate periodontal surgery
- severe gag reflex preventing maxillary surgical procedure
- inability or unwillingness 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 |
|---|---|---|
| Platelet Rich FibrinNative growth factors | Device | Palatal donor site NOT receiving PRF, Palatal donor site received PRF |
Primary outcome
Changes in Visual Analog scale (VAS)
Time frame: 1, 2, 3, 4 and 8 weeks
a visual analog scale (VAS) consisting a 10-cm line with two extremes at either end. "no pain" and "pain that could not be more severe". Patients were asked to mark a point on the line that represent their level of perceived pain
3 secondary outcomes
Changes in contour of the surgical area
Time frame: 1, 2, 3, 4 and 8 weeks
Changes in degree of color match
Time frame: 1, 2, 3, 4 and 8 weeks
Changes in tissue texture
Time frame: 1, 2, 3, 4 and 8 weeks
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 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Fibrin in people with Pain and Wound Healing, run by King Abdulaziz 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 4 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 Mar 2024. 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. 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?
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?
Changes in Visual Analog scale (VAS) (time frame: 1, 2, 3, 4 and 8 weeks). 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 Mar 2024.