Evaluation of the Effects of Injectable Platelet-Rich Fibrin and Hyaluronic Acid Treatments, Administered in Addition to Free Gingival Graft Therapy, on Clinical Healing.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaglik Bilimleri Universitesi

About this trial

The purpose of this clinical trial is to evaluate the effects of injectable platelet-rich fibrin (i-PRF) and hyaluronic acid (HA) gel on clinical healing and graft shrinkage when used in addition to Free Gingival Graft (FGG) surgery. The study involves patients with gingival recession and insufficient keratinized tissue. Participants will be randomly divided into three groups: FGG with i-PRF application, FGG with HA gel application, Conventional FGG alone (Control group). The main goal is to compare the amount of graft shrinkage and evaluate clinical wound healing parameters between these groups over a 3-month follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals aged 18 years or older.

Systemically healthy patients with no contraindications for periodontal surgery.

Patients presenting with gingival recession and/or inadequate width of keratinized tissue requiring Free Gingival Graft (FGG) therapy.

Non-smokers.

Disqualifiers

Patients with systemic diseases that may affect wound healing (e.g., uncontrolled diabetes mellitus, autoimmune disorders).

Pregnant or lactating individuals.

Patients with poor oral hygiene.

Current smokers or tobacco users.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Free gingival graft

    Procedure/Surgery

    The free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and directly applied and sutured to the recipient site without any additional biological agents.

  • Free Gingival Graft with i-PRF

    Procedure/Surgery

    The free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and hydrated in injectable platelet-rich fibrin (i-PRF) before fixation at the recipient site. i-PRF is prepared by centrifuging the patient's venous blood at 2500 rpm for 3 minutes.

  • Free Gingival Graft with Hyaluronic Acid

    Procedure/Surgery

    The free gingival graft is obtained from the palatal donor site (1-1.5 mm thickness) and soaked in 0.8% hyaluronic acid (HA) gel before fixation at the recipient site.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: FGG + i-PRFExperimental treatment 1 intervention
Group B: FGG + Hyaluronic AcidExperimental treatment 1 intervention
Group C: Conventional FGG (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Graft Shrinkage

Graft shrinkage will be evaluated by calculating the surface area of the graft in square millimeters using standardized clinical photographs and ImageJ software. The percentage of shrinkage is calculated with the formula: ((Immediate post-operative graft area - Follow-up graft area ) / Immediate post-operative graft area) x 100.

Time frame
Baseline, 1 month, and 3 months post-operation

Secondary outcomes

1

Probing Depth (PD)

Measurement of Probing Depth (PD) in millimeters using a UNC-15 periodontal probe.

Time frame
Baseline, 1 month, and 3 months post-operation
2

Wound Healing Index

Soft tissue healing will be assessed using the Landry, Turnbull, and Howley Index. Scores range from 1 (very poor) to 5 (excellent) based on parameters such as tissue color, bleeding on palpation, presence of granulation tissue, and incision margins.

Time frame
7 days, 14 days, 21 days, 1 month, and 3 months post-operation
3

Root Coverage Esthetic Score (RES)

Objective evaluation of the esthetic outcomes using the Root Coverage Esthetic Score (RES). The system evaluates five anatomical variables (gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color). The total score ranges from 0 to 10, with 10 representing a perfect esthetic outcome. Gingival Margin (GM): Scored as 0, 3, or 6 points depending on the amount of root coverage. Marginal Tissue Contour (MTC): 1 point if regular/proper, 0 points if irregular. Soft Tissue Texture (STT): 1 point if harmonious with the adjacent tissue, 0 points if not. Mucogingival Junction Alignment (MGJ): 1 point if aligned with the adjacent MGJ, 0 points if not. Gingival Color (GC): 1 point if there is a color match with the adjacent tissue, 0 points if not. The total score ranges from a minimum of 0 to a maximum of 10, where higher scores mean a better esthetic outcome.

Time frame
3 months post-operation
4

Clinical Attachment Level (CAL)

Measurement of clinical attachment level in millimeters using a UNC-15 periodontal probe.

Time frame
Baseline, 1 month, and 3 months post-operation

Other outcomes

1

Postoperative Pain

Postoperative pain intensity will be evaluated daily by the patients using a 10 cm Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.

Time frame
Up to 7 days post-operation
2

Patient-Reported Comfort Level: Postoperative Bleeding

Patient-reported comfort levels regarding postoperative bleeding will be assessed daily using a 5-point Likert scale. The scale ranges from 1 to 5 (1 = Very dissatisfied, 5 = Very satisfied), where higher scores indicate greater aesthetic satisfaction. minimum 1 to a maximum of 5, where higher scores mean a better outcome.

Time frame
Up to 14 days post-operation
3

Patient-Reported Comfort Level: Postoperative Edema

Patient-reported comfort levels regarding postoperative edema will be assessed daily using a 5-point Likert scale. The scale ranges from 1 to 5 (1 = Very dissatisfied, 5 = Very satisfied), where higher scores indicate greater aesthetic satisfaction. minimum 1 to a maximum of 5, where higher scores mean a better outcome.

Time frame
Up to 14 days post-operation
4

Patient-Reported Comfort Level: Difficulty Speaking

Patient-reported comfort level regarding difficulty speaking will be assessed daily using a 5-point Likert scale. The score ranges from a minimum of 1 to a maximum of 5 (1 = Very dissatisfied/Severe discomfort, 5 = Very satisfied/No discomfort), where higher scores mean a better outcome (greater patient comfort).

Time frame
Up to 14 days post-operation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: