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

NCT ID: NCT06865092

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-05-01

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.

Detailed Description

All patients diagnosed with chronic inflammatory gingival overgrowth based on clinical and radiological examinations underwent initial periodontal treatment (IPT) following baseline clinical periodontal assessments. Additionally, they received comprehensive oral hygiene instructions. After three weeks, patients were recalled for follow-up, and clinical periodontal parameters were re-evaluated. Gingivectomy and gingivoplasty surgery were planned.

Gingival growth was graded according to the following indices: The buccolingual aspect of gingival growth was classified according to the MB index (defined by Seymour and later modified by Miranda et al.) and the vertical aspect was classified according to the GOI index (defined by Angelopoulos and Goaz and later modified by Miller et al.). Patients presenting with a score greater than 0 in both indices were included in the study.

A total of four groups were planned in the study: one control group and three test groups.

• Test Group 1: Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing.
• Test Group 2: Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing.
• Test Group 3: Following gingivectomy with the conventional method, 0.8% HA (Gengigel; Ricerfarma, Milan, Italy) is applied to the wound site and covered with periodontal dressing.
• Control Group: Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials.

Clinical periodontal parameters were evaluated at baseline (T0), after IPT (T1), and in the 1st month after gingivectomy and gingivoplasty (T2). The gingival index (GI; Loe and Silness GI), plaque index (PI; Turesky-Gilmore-Glickman modification of the Quigley-Hein PI), bleeding on probing index (BOP), and probing depth (PD) were recorded. Using a Williams periodontal probe, the GI, BOP, and PD were assessed at six sites per tooth (excluding the third molar): three sites on the buccal surface (disto-buccal/labial, mesio-buccal/labial, and mid-buccal/labial) and three sites on the lingual surface (disto-lingual/palatal, mesio-lingual/palatal, and mid-lingual/palatal).

Conventional gingivectomy and gingivoplasty procedures were performed under local infiltration anesthesia. A 45-degree inclined external bevel incision was made using a surgical scalpel (Carbon, No. 15) and a gingivectomy blade (Hu-Friedy 15/16, Chicago, USA), starting from the distal end of the incision line. The interdental area was shaped using an Orban knife (Hu-Friedy 1/2, Chicago, USA), and any remaining granulation tissue was carefully removed from the surrounding area with curettes and scissors (Hu-Friedy, Chicago, USA). Finally, gingivoplasty was completed using a Kirkland knife (Hu-Friedy, Chicago, USA).

After the surgical procedures were completed, the control group areas were left to heal spontaneously. The other groups were treated with i-prf, t-prf, or 0.8% HA. Surgical areas in the control and test sites were covered with periodontal dressing (Coepak, Isip, IL, USA).

Patients were advised to avoid hot foods, to consume soft foods, and to keep the dressing in the mouth until the next examination. Patients were prescribed mouthwash containing 0.12% chlorhexidine and analgesic containing paracetamol to be used twice a day for one week.

Conditions

Gingival Overgrowth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

•I-PRF Group

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

Group Type: EXPERIMENTAL

injectable platelet-rich fibrin

Intervention Type: 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.

• T-PRF Group

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

Group Type: EXPERIMENTAL

titanium-prepared platelet-rich fibrin

Intervention Type: 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.

•HA Group

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

Group Type: EXPERIMENTAL

Hyaluronic Acid (HA)

Intervention Type: DRUG

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

•Control Group

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

Group Type: EXPERIMENTAL

control group

Intervention Type: OTHER

Nothing has applied.

Interventions

injectable platelet-rich fibrin

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.

Intervention Type: BIOLOGICAL

titanium-prepared platelet-rich fibrin

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.

Intervention Type: BIOLOGICAL

Hyaluronic Acid (HA)

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

Intervention Type: DRUG

control group

Nothing has applied.

Intervention Type: OTHER

Other Intervention Names

i-prf; t-prf; HA; 0.8% HA

Eligibility Criteria

Inclusion Criteria

1. ≥18-65 years of age

2. Being systemically healthy

3. Having chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior region, with no attachment and bone loss

4. Not to have used any medication in the last three months

5. Not smoking

6. At least 20 natural teeth

Exclusion Criteria

1. Patients with orthodontic appliances

2. Patients with removable (partial) prostheses

3. 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

4. Patients with oral and/or peri-oral pain

5. Patients with significant oral lesions

6. Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding

7. Patients who have undergone periodontal treatment within the last 6 months

8. Patients with poor communication skills

9. Smokers and alcohol users

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Özlem SARAÇ ATAGÜN

Asst. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

özlem saraç atagün, PhD

Role: PRINCIPAL_INVESTIGATOR

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD

Locations

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

OSATAGUN3

Identifier Type: -

Identifier Source: org_study_id