Palate; WoundNCT06242314
L-PRF Versus A-PRF on Palatal Wound Healing
A study testing L_PRF, A-PRF and Palatal stent in people with Palate; Wound, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Different approaches are used to reduce post-operative complications associated with the palatal wound site after free gingival graft (FGG) harvesting. The aim of this study was to compare the effects of L-PRF and A-PRF on palatal wound healing after free gingival graft harvesting and patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Palate; Wound
- What is being tested?
- L_PRF, A-PRF and Palatal stent
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 24 Oct 2022
- 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
- Patients ≥18 years requiring FGG surgery because of shallow vestibule and insufficient keratinized/attached gingival width
Who cannot join
- no smoking /no alcohol use,
- not suffering from any systemic disease that could impair the healing of wounds,
- pregnancy or lactation,
- Previous graft harvesting from the same site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effect of A-PRF and L-PRF Application to The Palatal Region on Quality of Life and Wound Healing After Free Gingival Graft Surgery
Different approaches are used to reduce post-operative complications associated with the palatal wound site after free gingival graft (FGG) harvesting. The aim of this study was to compare the effects of L-PRF and A-PRF on palatal wound healing after free gingival graft harvesting and patients' quality of life.
Read the detailed description
Thirty-six patients between the ages of 18 and 60 years (11 males and 25 females) who had completed Phase 1 periodontal treatments and for whom FGG surgery was indicated for isolated gingival recession defects limited to one or two teeth with shallow vestibule and insufficient keratinized or attached gingival width were included in the present study.
Three different treatments were performed on palatal wound areas: L-PRF (L-PRF group, n = 12), A-PRF (A-PRF group, n = 12) and palatal stent (control group, n = 12) OHIP-14 scores, VAS scores (for pain), analgesic tablet intake, and epithelialization condition were recorded for different time points.
- Conditions
- Palate; Wound
- Being tested
- L_PRF, A-PRF, Palatal stent
- Keywords
- free gingival graft, platelet rich fibrin
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L_PRFProcedure or surgery
Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after L-PRF placing on palatal wounds
A-PRFProcedure or surgery
Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after A-PRF placing on palatal wounds
Palatal stentProcedure or surgery
Palatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after palatal stent placing on palatal wounds
| Study group | Role | What they receive |
|---|---|---|
| L-PRF | Experimental | L-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture. Receives: Procedure: L_PRF |
| A-PRF | Experimental | A-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture. Receives: Procedure: A-PRF |
| Palatal stent | Placebo comparator | Palatal stent was prepared by taking impression of the palate before surgery. After FGG harvesting, periodontal paste (COE-PAK periodontal dressing, GC, Illinois, USA) was applied on the wound surface of the palatal stent and the palate was closed. Receives: Procedure: Palatal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelialization
Hydrogen peroxide (H2O2) test was used to evaluate the integrity of epithelialization
Measured: 1 month
Secondary outcomes (3)
Pain at Palatal wound area
Postoperative pain was evaluated using a 10-cm Visual Analog Scale (VAS) score during the first week and on day 14. The left end-point represented "no pain," while the right end-point represented "severe pain at its highest." In order to rate their pain, the participants were requested to indicate the VAS line with the appropriate postoperative pain level. A ruler was then used to measure the distance between the "no pain" point and the rated line, providing a pain score between 0 and 10
Measured: First 7 days and day 14
Pain at Palatal wound area
The average amount of ibuprofen 600 mg pills needed to control postoperative discomfort during the seven days after surgery was recorded as the total number of pills consumed.
Measured: First 7 days
Oral health-related quality of life (OHRQoL)
Oral health-related quality of life of patients was assessed by the Oral Health Impact Profile-14 (OHIP-14) questionnaire.OHIP-14 uses 14 structured questions and answers to assess seven subjective dimensions. The evaluated dimensions are functional limitations, physical pain, psychologic discomfort, physical disability, psychologic disability, social disability, and handicap. Patients responded to the questionnaire using Likert scale answers (0- never; 1-almost never; 2-occasionally; 3-quite frequent; 4-very common) on the 7th and 14th day after surgery. In this way, the questionnaire ranges from 0 to 56 points, with higher scores indicating more negative impact of oral conditions on quality of life.Thus, patients' experiences about the surgery in the first two weeks postoperatively were recorded.
Measured: 7 and 14 days after free gingival graft surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start10 Jan 2021
- Primary completion22 Mar 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palate; WoundStudies of the same condition, open and under way.
- More trials run by Izmir Katip Celebi 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Dr. Mehmet Sağlam, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242314
- Sponsor's protocol ID
- 1090/2020
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effect of A-PRF and L-PRF Application to The Palatal Region on Quality of Life and Wound Healing After Free Gingival Graft Surgery
- ClinicalTrials.gov ID
- NCT06242314
- Acronym / sponsor ID
- 1090/2020
- Conditions
- Palate; Wound
- Keywords
- free gingival graft, platelet rich fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 5 Feb 2024 (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.
Different approaches are used to reduce post-operative complications associated with the palatal wound site after free gingival graft (FGG) harvesting. The aim of this study was to compare the effects of L-PRF and A-PRF on palatal wound healing after free gingival graft harvesting and patients' quality of life.
Detailed description
Thirty-six patients between the ages of 18 and 60 years (11 males and 25 females) who had completed Phase 1 periodontal treatments and for whom FGG surgery was indicated for isolated gingival recession defects limited to one or two teeth with shallow vestibule and insufficient keratinized or attached gingival width were included in the present study.
Three different treatments were performed on palatal wound areas: L-PRF (L-PRF group, n = 12), A-PRF (A-PRF group, n = 12) and palatal stent (control group, n = 12) OHIP-14 scores, VAS scores (for pain), analgesic tablet intake, and epithelialization condition were recorded for different time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L-PRF | Experimental | Procedure: L_PRFL-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture. |
| A-PRF | Experimental | Procedure: A-PRFA-PRF was laid directly on the palatal wound immediately after free gingival graft harvesting and stabilized with silk suture. |
| Palatal stent | Placebo comparator | Procedure: Palatal stentPalatal stent was prepared by taking impression of the palate before surgery. After FGG harvesting, periodontal paste (COE-PAK periodontal dressing, GC, Illinois, USA) was applied on the wound surface of the palatal stent and the palate was closed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients ≥18 years requiring FGG surgery because of shallow vestibule and insufficient keratinized/attached gingival width
Key exclusion criteria (4 listed)
- no smoking /no alcohol use,
- not suffering from any systemic disease that could impair the healing of wounds,
- pregnancy or lactation,
- Previous graft harvesting from the same site.
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_PRFPalatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after L-PRF placing on palatal wounds | Procedure or surgery | L-PRF |
| A-PRFPalatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after A-PRF placing on palatal wounds | Procedure or surgery | A-PRF |
| Palatal stentPalatal epithelialization, pain (Visual Analog Scale (VAS) recording), analgesic tablet use and Oral Health Impact Profile-14 (OHIP-14) questionnaire scores were recorded after palatal stent placing on palatal wounds | Procedure or surgery | Palatal stent |
Primary outcome
Epithelialization
Time frame: 1 month
Hydrogen peroxide (H2O2) test was used to evaluate the integrity of epithelialization
3 secondary outcomes
Pain at Palatal wound area
Time frame: First 7 days and day 14
Pain at Palatal wound area
Time frame: First 7 days
Oral health-related quality of life (OHRQoL)
Time frame: 7 and 14 days after free gingival graft surgery
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 5 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L_PRF, A-PRF and Palatal stent in people with Palate; Wound, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 5 Feb 2024. 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 Turkey (Türkiye). 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. 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.
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?
Epithelialization (time frame: 1 month). 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 5 Feb 2024.