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

Not Applicable

Active, not recruiting

• Conditions: Gingival Overgrowth
• Interventions: Biological: injectable platelet-rich fibrin; Biological: titanium-prepared platelet-rich fibrin; Drug: Hyaluronic Acid (HA); Other: control group

• Registration Number: NCT06865092
• Lead Sponsor: Saglik Bilimleri Universitesi

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.

Study Timeline

• Study Start: 2023-05-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-19
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
•I-PRF Group	injectable platelet-rich fibrin	Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing.
• T-PRF Group	titanium-prepared platelet-rich fibrin	Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing.
•HA Group	Hyaluronic Acid (HA)	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	control group	: Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials.

Primary Outcome Measures

Name	Time	Method
Evaluation of wound epithelialization	after gingivectomy (Day 0), Day 7, Day 14, Day 21, Day 28	Evaluation of wound epithelialization with Mira-2 tone Solution
LTH wound healing index	Day 7, Day 14, Day 21, Day 28	Assessment of soft tissue healing with Landry, Turnbull, and Howley (LTH) index

Secondary Outcome Measures

Name	Time	Method
H2O2 foaming test	Day 7, Day 14, Day 21, Day 28	H2O2 foaming test (evaluation of wound epithelialization)
Pain and burning scores	After gingivectomy Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7	Pain and burning scores were evaluated with VAS.
Gingival index (GI)	Baseline, 3 weeks, Day 28 after gingivectomy	Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Plaque index (PI)	Baseline, 3 weeks, Day 28 after gingivectomy	Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5
Bleeding on Probing (BOP)	Baseline, 3 weeks, Day 28 after gingivectomy	Improvement in PBI; lower scores mean a better outcome; Minimum score: %0 Max.score: %100
Pocket depth (PD)	Baseline, 3 weeks, Day 28 after gingivectomy	Improvement in PD; lower scores mean a better outcome
OHIP-14	Baseline, Day 7, Day 14 after gingivectomy	Improvement in Oral Health Impact Profile (OHIP-14) ; lower scores mean a better outcome

Trial Locations

Locations (1)

Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi; 🇹🇷 Ankara, Turkey