Graft ShrinkageNCT07303192
Effect of i-PRF and LLLT on Free Gingival Graft Shrinkage
A study testing Free Gingival Graft (FGG), Injectable Platelet-Rich Fibrin (i-PRF) and Low-Level Laser Therapy (LLLT) in people with Graft Shrinkage and Gingival Recession, Localized, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This randomized clinical trial aims to evaluate whether injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) can reduce graft shrinkage after free gingival graft procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft Shrinkage, Gingival Recession, Localized
- What is being tested?
- Free Gingival Graft (FGG), Injectable Platelet-Rich Fibrin (i-PRF) and Low-Level Laser Therapy (LLLT)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Systemically healthy.
- Cairo Class I gingival recession in vital mandibular anterior incisors.
- No caries or restorations in the relevant teeth.
- Keratinized gingiva height < 2 mm in the included teeth.
- Plaque Index (PI) < 1.
- Gingival Index (GI) < 1.
Who cannot join
- Active periodontal disease or probing depth > 3 mm.
- Use of medications that could prevent surgery or affect wound healing.
- Pregnancy or breastfeeding.
- History of periodontal surgery in the working area.
- Active smokers.
- Current orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş
About this study
Official title: The Effect of Injectable Platelet-Rich Fibrin and Low-Level Laser Therapy on Graft Shrinkage in Free Gingival Grafts: A Randomized Controlled Clinical Trial
This randomized clinical trial aims to evaluate whether injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) can reduce graft shrinkage after free gingival graft procedures. Free gingival grafts are commonly used to increase the width of keratinized tissue around teeth, but the graft often shrinks during healing. In this study, patients will receive standard free gingival graft surgery with or without additional i-PRF or laser therapy. The goal is to determine whether these treatments improve healing and help maintain the size of the graft.
Read the detailed description
This randomized controlled clinical trial investigates the effects of injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) on the shrinkage of free gingival grafts (FGG) used to treat gingival recession. Free gingival grafting is commonly performed to increase the width of keratinized tissue around teeth, but shrinkage during healing can reduce clinical outcomes.
The study included 48 systemically healthy adult patients with Cairo Class I gingival recession in mandibular anterior teeth. Participants were randomly assigned to one of three groups: control (FGG alone), i-PRF (FGG + platelet-rich fibrin), or LLLT (FGG + low-level laser therapy). Ethical approval was obtained from the Clinical Research Ethics Committee of Inonu University (Protocol No: 2024/84), and all participants provided written informed consent. The study protocol was registered at ClinicalTrials.gov (NCT06744270) and conducted according to CONSORT 2010 guidelines.
All patients received preoperative periodontal treatment, including plaque removal and oral hygiene instructions. Free gingival grafts were harvested from the palatal region and adapted to the recipient site, then stabilized with sutures. In the i-PRF group, autologous platelet-rich fibrin gel was applied to the graft surface. In the LLLT group, laser therapy was applied immediately after surgery and on postoperative days 3, 5, 7, and 14. The control group received no additional treatment beyond standard grafting.
Postoperative care included use of a periodontal dressing, chlorhexidine mouthwash, analgesics as needed, and oral hygiene instructions after suture removal. Clinical evaluations included gingival recession depth, keratinized tissue height, probing depth, clinical attachment level, and graft area measurements at baseline, 1, 3, and 6 months. Edema, erythema, and patient-reported pain were also assessed during follow-up.
The primary outcome of the study was graft shrinkage, calculated as the percentage decrease in graft area over time. Secondary outcomes included clinical parameters and patient-reported postoperative morbidity. All measurements were performed by calibrated, blinded examiners to ensure reliability.
- Conditions
- Graft Shrinkage, Gingival Recession, Localized
- Being tested
- Free Gingival Graft (FGG), Injectable Platelet-Rich Fibrin (i-PRF), Low-Level Laser Therapy (LLLT)
- Keywords
- free gingival graft, shrinkage, low-level laser therapy, injectable platelet-rich fibrin
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free Gingival Graft (FGG)Procedure or surgery
Standard free gingival graft procedure performed without additional treatments.
Injectable Platelet-Rich Fibrin (i-PRF)Biological
Autologous platelet-rich fibrin gel is applied to the graft surface after free gingival graft surgery to potentially reduce graft shrinkage.
Low-Level Laser Therapy (LLLT)Device
Low-level laser therapy is applied to the graft site immediately after surgery and on postoperative days 3, 5, 7, and 14 to potentially improve healing and reduce graft shrinkage.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients receive free gingival graft only without additional treatment. Receives: Procedure: Free Gingival Graft (FGG) |
| i-PRF group | Experimental | Patients receive free gingival graft with injectable platelet-rich fibrin applied to the graft surface. Receives: Procedure: Free Gingival Graft (FGG); Device: Low-Level Laser Therapy (LLLT) |
| LLLT Group | Experimental | Patients receive free gingival graft with low-level laser therapy applied immediately after surgery and on postoperative days 3, 5, 7, and 14. Receives: Procedure: Free Gingival Graft (FGG); Biological: Injectable Platelet-Rich Fibrin (i-PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Area Shrinkage (%)
Change in graft surface area, expressed as percentage shrinkage from baseline. Standardized clinical photographs taken at baseline and at postoperative 1, 3, and 6 months were analyzed using calibrated digital image analysis software (ImageJ). The graft borders were traced, and surface area (mm²) was calculated. Each measurement was repeated three times, and the mean value was used. Shrinkage percentage was calculated using the formula:
Shrinkage % = [(baseline area - follow-up area) / baseline area] × 100.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively.
Root Coverage Percentage (%)
Percentage of root coverage obtained at 6 months. Root coverage was calculated from changes in gingival recession depth (RD) using the formula:
Root Coverage % = [(baseline RD - RD at 6 months) / baseline RD] × 100. RD was defined as the distance from the CEJ to the gingival margin and measured using a manual periodontal probe.
Measured: Baseline and 6 months postoperatively.
Gingival Recession Depth (RD)
Change in gingival recession depth measured in millimeters.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively.
Keratinized Tissue Height (KTH)
Change in keratinized tissue height measured in millimeters.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively.
Secondary outcomes (6)
Probing Depth (PD)
Change in probing depth measured in millimeters.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively.
Clinical Attachment Level (CAL)
Change in clinical attachment level measured in millimeters.
Measured: Baseline, 1 month, 3 months, and 6 months postoperatively.
Oedema Score in the Recipient Site
Oedema was scored clinically in the recipient area using a 0-4 ordinal scale (0 = none; 1 = mild, intraoral oedema limited to the surgical site; 2 = moderate, extraoral oedema limited to the surgical site; 3 = significant, extraoral oedema extending beyond the surgical site; 4 = severe, extraoral oedema extending beyond the surgical site with limited mouth opening). Examinations were performed by a calibrated and blinded examiner. Higher scores indicate more severe oedema.
Unit of Measure: Units on a scale (0-4)
Measured: Postoperative days 3, 5, 7, 14, 21, and 28.
Erythema Score in the Recipient Site
Erythema was scored clinically in the recipient area using a 0-4 ordinal scale (0 = none, tissues fully pink; 1 = mild, <25% of tissues red; 2 = moderate, 25-50% of tissues red; 3 = significant, 50-75% of tissues red; 4 = severe, >75% of tissues red). Examinations were performed by a calibrated and blinded examiner. Higher scores indicate greater severity of erythema.
Measured: Postoperative days 3, 5, 7, 14, 21, and 28.
Pain Intensity (VAS Score)
Postoperative pain intensity was assessed using a 0-10 Visual Analog Scale (VAS), where 0 = no pain and 10 = maximum tolerable pain. Patients recorded their pain level daily during the first postoperative week. Higher scores indicate greater pain intensity.
Measured: First postoperative week.
Analgesic Consumption
The number of analgesic tablets taken during the first postoperative week was recorded by each patient on a provided daily log form. Higher values indicate greater postoperative analgesic use.
Measured: First postoperative week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Jul 2024
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Graft ShrinkageStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Bozkurt, Kahramanmaras Sutcu Imam University
- Investigators
- esra bozkurt, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303192
- Sponsor's protocol ID
- 2024/84
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to ensure patient privacy and confidentiality.
Publications
Shakiliyeva S, Sahin D, Gunpinar S, Gursel M. Comparison of conventional and modified sling suture techniques in free gingival graft operations-a randomized controlled clinical trial. BMC Oral Health. 2025 Feb 21;25(1):279. doi: 10.1186/s12903-025-05456-x.
PubMed 39984903Bozkurt E, Ozdemir EC. The Effect of injectable platelet-rich fibrin and low-level laser therapy on graft shrinkage in free gingival grafts: a randomized controlled clinical trial. BMC Oral Health. 2026 Apr 13;26(1):990. doi: 10.1186/s12903-026-08309-3.
PubMed 41975378
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Injectable Platelet-Rich Fibrin and Low-Level Laser Therapy on Graft Shrinkage in Free Gingival Grafts: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07303192
- Acronym / sponsor ID
- 2024/84
- Conditions
- Graft Shrinkage, Gingival Recession, Localized
- Keywords
- free gingival graft, shrinkage, low-level laser therapy, injectable platelet-rich fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 24 Dec 2025 (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.
This randomized clinical trial aims to evaluate whether injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) can reduce graft shrinkage after free gingival graft procedures. Free gingival grafts are commonly used to increase the width of keratinized tissue around teeth, but the graft often shrinks during healing. In this study, patients will receive standard free gingival graft surgery with or without additional i-PRF or laser therapy. The goal is to determine whether these treatments improve healing and help maintain the size of the graft.
Detailed description
This randomized controlled clinical trial investigates the effects of injectable platelet-rich fibrin (i-PRF) and low-level laser therapy (LLLT) on the shrinkage of free gingival grafts (FGG) used to treat gingival recession. Free gingival grafting is commonly performed to increase the width of keratinized tissue around teeth, but shrinkage during healing can reduce clinical outcomes.
The study included 48 systemically healthy adult patients with Cairo Class I gingival recession in mandibular anterior teeth. Participants were randomly assigned to one of three groups: control (FGG alone), i-PRF (FGG + platelet-rich fibrin), or LLLT (FGG + low-level laser therapy). Ethical approval was obtained from the Clinical Research Ethics Committee of Inonu University (Protocol No: 2024/84), and all participants provided written informed consent. The study protocol was registered at ClinicalTrials.gov (NCT06744270) and conducted according to CONSORT 2010 guidelines.
All patients received preoperative periodontal treatment, including plaque removal and oral hygiene instructions. Free gingival grafts were harvested from the palatal region and adapted to the recipient site, then stabilized with sutures. In the i-PRF group, autologous platelet-rich fibrin gel was applied to the graft surface. In the LLLT group, laser therapy was applied immediately after surgery and on postoperative days 3, 5, 7, and 14. The control group received no additional treatment beyond standard grafting.
Postoperative care included use of a periodontal dressing, chlorhexidine mouthwash, analgesics as needed, and oral hygiene instructions after suture removal. Clinical evaluations included gingival recession depth, keratinized tissue height, probing depth, clinical attachment level, and graft area measurements at baseline, 1, 3, and 6 months. Edema, erythema, and patient-reported pain were also assessed during follow-up.
The primary outcome of the study was graft shrinkage, calculated as the percentage decrease in graft area over time. Secondary outcomes included clinical parameters and patient-reported postoperative morbidity. All measurements were performed by calibrated, blinded examiners to ensure reliability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Free Gingival Graft (FGG)Patients receive free gingival graft only without additional treatment. |
| i-PRF group | Experimental | Procedure: Free Gingival Graft (FGG), Device: Low-Level Laser Therapy (LLLT)Patients receive free gingival graft with injectable platelet-rich fibrin applied to the graft surface. |
| LLLT Group | Experimental | Procedure: Free Gingival Graft (FGG), Biological: Injectable Platelet-Rich Fibrin (i-PRF)Patients receive free gingival graft with low-level laser therapy applied immediately after surgery and on postoperative days 3, 5, 7, and 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years.
- Systemically healthy.
- Cairo Class I gingival recession in vital mandibular anterior incisors.
- No caries or restorations in the relevant teeth.
- Keratinized gingiva height < 2 mm in the included teeth.
Key exclusion criteria (6 listed)
- Active periodontal disease or probing depth > 3 mm.
- Use of medications that could prevent surgery or affect wound healing.
- Pregnancy or breastfeeding.
- History of periodontal surgery in the working area.
- Active smokers.
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 |
|---|---|---|
| Free Gingival Graft (FGG)Standard free gingival graft procedure performed without additional treatments. | Procedure or surgery | Control Group, LLLT Group, i-PRF group |
| Injectable Platelet-Rich Fibrin (i-PRF)Autologous platelet-rich fibrin gel is applied to the graft surface after free gingival graft surgery to potentially reduce graft shrinkage. | Biological | LLLT Group |
| Low-Level Laser Therapy (LLLT)Low-level laser therapy is applied to the graft site immediately after surgery and on postoperative days 3, 5, 7, and 14 to potentially improve healing and reduce graft shrinkage. | Device | i-PRF group |
Primary outcome
Graft Area Shrinkage (%)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Change in graft surface area, expressed as percentage shrinkage from baseline. Standardized clinical photographs taken at baseline and at postoperative 1, 3, and 6 months were analyzed using calibrated digital image analysis software (ImageJ). The graft borders were traced, and surface area (mm²) was calculated. Each measurement was repeated three times, and the mean value was used. Shrinkage percentage was calculated using the formula: Shrinkage % = [(baseline area - follow-up area) / baseline area] × 100.
Root Coverage Percentage (%)
Time frame: Baseline and 6 months postoperatively.
Percentage of root coverage obtained at 6 months. Root coverage was calculated from changes in gingival recession depth (RD) using the formula: Root Coverage % = [(baseline RD - RD at 6 months) / baseline RD] × 100. RD was defined as the distance from the CEJ to the gingival margin and measured using a manual periodontal probe.
Gingival Recession Depth (RD)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Change in gingival recession depth measured in millimeters.
Keratinized Tissue Height (KTH)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Change in keratinized tissue height measured in millimeters.
6 secondary outcomes
Probing Depth (PD)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Clinical Attachment Level (CAL)
Time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.
Oedema Score in the Recipient Site
Time frame: Postoperative days 3, 5, 7, 14, 21, and 28.
Erythema Score in the Recipient Site
Time frame: Postoperative days 3, 5, 7, 14, 21, and 28.
Pain Intensity (VAS Score)
Time frame: First postoperative week.
Analgesic Consumption
Time frame: First postoperative week.
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 24 Dec 2025.
- Background: PubMed 39984903Shakiliyeva S, Sahin D, Gunpinar S, Gursel M. Comparison of conventional and modified sling suture techniques in free gingival graft operations-a randomized controlled clinical trial. BMC Oral Health. 2025 Feb 21;25(1):279. doi: 10.1186/s12903-025-05456-x.
- Derived from this study: PubMed 41975378Bozkurt E, Ozdemir EC. The Effect of injectable platelet-rich fibrin and low-level laser therapy on graft shrinkage in free gingival grafts: a randomized controlled clinical trial. BMC Oral Health. 2026 Apr 13;26(1):990. doi: 10.1186/s12903-026-08309-3.
- Inonu University Clinical Research Ethics CommitteeLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to ensure patient privacy and confidentiality.
Related trials for Graft Shrinkage
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Not yet recruitingObservational study
Reharvested Free Gingival Grafts: 3D Shrinkage and Histological Changes
Insufficient Keratinized Gingiva
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.
esra bozkurt principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free Gingival Graft (FGG), Injectable Platelet-Rich Fibrin (i-PRF) and Low-Level Laser Therapy (LLLT) in people with Graft Shrinkage and Gingival Recession, Localized, run by Kahramanmaras Sutcu Imam 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 7 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 24 Dec 2025. 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. 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?
Graft Area Shrinkage (%) (time frame: Baseline, 1 month, 3 months, and 6 months postoperatively.). 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?
On the ClinicalTrials.gov record for NCT07303192, which also lists 2 linked publications.
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 24 Dec 2025.