Comparison of I-PRF, T-PRF, and 0.8% Hyaluronic Acid Applications in Wound Healing After Gingivectomy.

NCT06865092 | Completed DMC

• 1 other identifier: OSATAGUN3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: This study aimed to evaluate the effect of injectable platelet-rich fibrin (i-prf), titanium-prepared platelet-rich fibrin (t-prf), and 0.8% hyaluronic acid (HA) gel on clinical periodontal parameters, wound healing, patient comfort and satisfaction after gingivectomy and gingivoplasty procedures routinely performed in the treatment of chronic inflammatory gingival overgrowth. Materials and methods: In this clinical study, 60 systemically healthy patients with chronic inflammatory gingival overgrowth were randomly assigned to i-prf (n=15), t-prf (n=15), 0.8% HA (n=15), or control (n=15) groups and treated with gingivectomy and gingivoplasty after initial periodontal treatment. Pain and burning scores were evaluated with VAS 7 days after the procedures. Surgical areas were stained with Mira-2 tone and evaluated in ImageJ. Wound healing was evaluated using the Landry, Turnbull, and Howley (LTH) index and H2O2 foaming test at 7, 14, 21, and 28 days after the procedure. Clinical periodontal parameters assessed at baseline and 3 weeks after initial periodontal treatment were reassessed at 28 days following gingivectomy and gingivoplasty.

Conditions

Gingival Overgrowth

Keywords

Gingival Overgrowth; Hyaluronic Acid; I-PRF; T-PRF; Gingivectomy

Outcome Measures

Primary Outcomes (2)

• Evaluation of wound epithelialization

  Evaluation of wound epithelialization with Mira-2 tone Solution

  after gingivectomy (Day 0), Day 7, Day 14, Day 21, Day 28

• LTH wound healing index

  Assessment of soft tissue healing with Landry, Turnbull, and Howley (LTH) index

  Day 7, Day 14, Day 21, Day 28

Secondary Outcomes (7)

• H2O2 foaming test

  Day 7, Day 14, Day 21, Day 28

• Pain and burning scores

  After gingivectomy Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

• Gingival index (GI)

  Baseline, 3 weeks, Day 28 after gingivectomy

• Plaque index (PI)

  Baseline, 3 weeks, Day 28 after gingivectomy

• Bleeding on Probing (BOP)

  Baseline, 3 weeks, Day 28 after gingivectomy

Study Arms (4)

•I-PRF Group

EXPERIMENTAL

Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing.

Biological: injectable platelet-rich fibrin

• T-PRF Group

EXPERIMENTAL

Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing.

Biological: titanium-prepared platelet-rich fibrin

•HA Group

EXPERIMENTAL

Following gingivectomy with the conventional method, 0.8% HA (Gengigel; Ricerfarma, Milan, Italy) is applied to the wound site and covered with periodontal dressing.

Drug: Hyaluronic Acid (HA)

•Control Group

EXPERIMENTAL

: Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials.

Other: control group

Interventions

injectable platelet-rich fibrin BIOLOGICAL

Blood samples were collected in two 10 ml plastic tubes without anticoagulant. The tubes were centrifuged for 3 min at 2500 rpm in a centrifuge device and i-prf was obtained.

Also known as: i-prf

•I-PRF Group

titanium-prepared platelet-rich fibrin BIOLOGICAL

The blood was drawn into a 20 ml syringe and immediately divided into two sterile grade IV titanium tubes containing 10 ml of blood. The tubes were placed opposite each other and centrifuged at 2700 rpm for 12 minutes at room temperature and t-prf was obtained.

Also known as: t-prf

• T-PRF Group

Hyaluronic Acid (HA) DRUG

0.8% hyaluronic acid (HA) gel (Gengigel) was applied to the wound sites.

Also known as: HA, 0.8% HA

•HA Group

control group OTHER

Nothing has applied.

•Control Group

Eligibility Criteria

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

You may qualify if:

• ≥18-65 years of age
• Being systemically healthy
• Having chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior region, with no attachment and bone loss
• Not to have used any medication in the last three months
• Not smoking
• At least 20 natural teeth

You may not qualify if:

• Patients with orthodontic appliances
• Patients with removable (partial) prostheses
• Patients with immunosuppressive agents, systemic corticosteroids, chemotherapy, and/or radiotherapy drugs and/or drugs that may cause gingival enlargement use in the last 6 months
• Patients with oral and/or peri-oral pain
• Patients with significant oral lesions
• Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding
• Patients who have undergone periodontal treatment within the last 6 months
• Patients with poor communication skills
• Smokers and alcohol users

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Overgrowth

Interventions

proliferation regulatory factors, human urine; Hyaluronic Acid; Control Groups

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• özlem saraç atagün, PhD

  Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr.

Model Details: randomized controlled, single-blind, prospective clinical study

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: May 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)