- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06865092
Comparison of I-PRF, T-PRF, and 0.8% Hyaluronic Acid Applications in Wound Healing After Gingivectomy.
Comparison of Injectable Platelet-rich Fibrin, Titanium Platelet-rich Fibrin, and 0.8% Hyaluronic Acid Applications in Wound Healing After Gingivectomy and Gingivoplasty Operations: Randomized Controlled Clinical Study.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey (Türkiye), 06010
- Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: •I-PRF Group
Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing.
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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.
Other Names:
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Experimental: • T-PRF Group
Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing.
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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.
Other Names:
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Experimental: •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.
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0.8% hyaluronic acid (HA) gel (Gengigel) was applied to the wound sites.
Other Names:
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Experimental: •Control Group
: Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials.
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Nothing has applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of wound epithelialization
Time Frame: after gingivectomy (Day 0), Day 7, Day 14, Day 21, Day 28
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Evaluation of wound epithelialization with Mira-2 tone Solution
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after gingivectomy (Day 0), Day 7, Day 14, Day 21, Day 28
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LTH wound healing index
Time Frame: Day 7, Day 14, Day 21, Day 28
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Assessment of soft tissue healing with Landry, Turnbull, and Howley (LTH) index
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Day 7, Day 14, Day 21, Day 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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H2O2 foaming test
Time Frame: Day 7, Day 14, Day 21, Day 28
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H2O2 foaming test (evaluation of wound epithelialization)
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Day 7, Day 14, Day 21, Day 28
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Pain and burning scores
Time Frame: After gingivectomy Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
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Pain and burning scores were evaluated with VAS.
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After gingivectomy Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
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Gingival index (GI)
Time Frame: Baseline, 3 weeks, Day 28 after gingivectomy
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Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
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Baseline, 3 weeks, Day 28 after gingivectomy
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Plaque index (PI)
Time Frame: Baseline, 3 weeks, Day 28 after gingivectomy
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Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5
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Baseline, 3 weeks, Day 28 after gingivectomy
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Bleeding on Probing (BOP)
Time Frame: Baseline, 3 weeks, Day 28 after gingivectomy
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Improvement in PBI; lower scores mean a better outcome; Minimum score: %0 Max.score: %100
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Baseline, 3 weeks, Day 28 after gingivectomy
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Pocket depth (PD)
Time Frame: Baseline, 3 weeks, Day 28 after gingivectomy
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Improvement in PD; lower scores mean a better outcome
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Baseline, 3 weeks, Day 28 after gingivectomy
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OHIP-14
Time Frame: Baseline, Day 7, Day 14 after gingivectomy
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Improvement in Oral Health Impact Profile (OHIP-14) ; lower scores mean a better outcome
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Baseline, Day 7, Day 14 after gingivectomy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: özlem saraç atagün, PhD, Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Periodontal Diseases
- Mouth Diseases
- Stomatognathic Diseases
- Gingival Diseases
- Gingival Overgrowth
- Investigative Techniques
- Epidemiologic Research Design
- Epidemiologic Methods
- Research Design
- Methods
- Carbohydrates
- Glycosaminoglycans
- Polysaccharides
- Hyaluronic Acid
- Control Groups
- proliferation regulatory factors, human urine
Other Study ID Numbers
- OSATAGUN3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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