Effect of i-PRF and LLLT on Free Gingival Graft Shrinkage
NCT ID: NCT07303192
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2024-07-01
2025-08-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control Group
Patients receive free gingival graft only without additional treatment.
Free Gingival Graft (FGG)
Standard free gingival graft procedure performed without additional treatments.
i-PRF group
Patients receive free gingival graft with injectable platelet-rich fibrin applied to the graft surface.
Free Gingival Graft (FGG)
Standard free gingival graft procedure performed without additional treatments.
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.
LLLT Group
Patients receive free gingival graft with low-level laser therapy applied immediately after surgery and on postoperative days 3, 5, 7, and 14.
Free Gingival Graft (FGG)
Standard free gingival graft procedure performed without additional treatments.
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.
Interventions
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Free Gingival Graft (FGG)
Standard free gingival graft procedure performed without additional treatments.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Kahramanmaras Sutcu Imam University
OTHER
Responsible Party
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Esra Bozkurt
Assistant Professor
Principal Investigators
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esra bozkurt
Role: PRINCIPAL_INVESTIGATOR
Kahramanmaras Sutcu Imam University
Locations
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Kahramanmaraş Sütçü İmam University
Kahramanmaraş, , Turkey (Türkiye)
Countries
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References
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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.
Related Links
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Inonu University Clinical Research Ethics Committee
Other Identifiers
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2024/84
Identifier Type: -
Identifier Source: org_study_id