Effect of i-PRF and LLLT on Free Gingival Graft Shrinkage

NCT07303192 | Completed

• 1 other identifier: 2024/84
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Graft Shrinkage; Gingival Recession, Localized

Keywords

free gingival graft; shrinkage; low-level laser therapy; injectable platelet-rich fibrin

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Baseline and 6 months postoperatively.

• Gingival Recession Depth (RD)

  Change in gingival recession depth measured in millimeters.

  Baseline, 1 month, 3 months, and 6 months postoperatively.

• Keratinized Tissue Height (KTH)

  Change in keratinized tissue height measured in millimeters.

  Baseline, 1 month, 3 months, and 6 months postoperatively.

Secondary Outcomes (6)

• Probing Depth (PD)

  Baseline, 1 month, 3 months, and 6 months postoperatively.

• Clinical Attachment Level (CAL)

  Baseline, 1 month, 3 months, and 6 months postoperatively.

• Oedema Score in the Recipient Site

  Postoperative days 3, 5, 7, 14, 21, and 28.

• Erythema Score in the Recipient Site

  Postoperative days 3, 5, 7, 14, 21, and 28.

• Pain Intensity (VAS Score)

  First postoperative week.

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Patients receive free gingival graft only without additional treatment.

Procedure: Free Gingival Graft (FGG)

i-PRF group

EXPERIMENTAL

Patients receive free gingival graft with injectable platelet-rich fibrin applied to the graft surface.

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.

Procedure: Free Gingival Graft (FGG); Biological: Injectable Platelet-Rich Fibrin (i-PRF)

Interventions

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.

LLLT Group

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.

i-PRF group

Free Gingival Graft (FGG) PROCEDURE

Standard free gingival graft procedure performed without additional treatments.

Control Group; LLLT Group; i-PRF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39984903 BACKGROUND

Related Links

• Inonu University Clinical Research Ethics Committee

MeSH Terms

Conditions

Gingival Recession

Interventions

proliferation regulatory factors, human urine; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• esra bozkurt

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: July 1, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)