Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-02 @ 7:52 AM
Study NCT ID:
NCT06865092
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-19
First Post:
2025-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of I-PRF, T-PRF, and 0.8% Hyaluronic Acid Applications in Wound Healing After Gingivectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019214', 'term': 'Gingival Overgrowth'}], 'ancestors': [{'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043309', 'term': 'proliferation regulatory factors, human urine'}, {'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled, single-blind, prospective clinical study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of wound epithelialization', 'timeFrame': 'after gingivectomy (Day 0), Day 7, Day 14, Day 21, Day 28', 'description': 'Evaluation of wound epithelialization with Mira-2 tone Solution'}, {'measure': 'LTH wound healing index', 'timeFrame': 'Day 7, Day 14, Day 21, Day 28', 'description': 'Assessment of soft tissue healing with Landry, Turnbull, and Howley (LTH) index'}], 'secondaryOutcomes': [{'measure': 'H2O2 foaming test', 'timeFrame': 'Day 7, Day 14, Day 21, Day 28', 'description': 'H2O2 foaming test (evaluation of wound epithelialization)'}, {'measure': 'Pain and burning scores', 'timeFrame': 'After gingivectomy Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7', 'description': 'Pain and burning scores were evaluated with VAS.'}, {'measure': 'Gingival index (GI)', 'timeFrame': 'Baseline, 3 weeks, Day 28 after gingivectomy', 'description': 'Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3'}, {'measure': 'Plaque index (PI)', 'timeFrame': 'Baseline, 3 weeks, Day 28 after gingivectomy', 'description': 'Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5'}, {'measure': 'Bleeding on Probing (BOP)', 'timeFrame': 'Baseline, 3 weeks, Day 28 after gingivectomy', 'description': 'Improvement in PBI; lower scores mean a better outcome; Minimum score: %0 Max.score: %100'}, {'measure': 'Pocket depth (PD)', 'timeFrame': 'Baseline, 3 weeks, Day 28 after gingivectomy', 'description': 'Improvement in PD; lower scores mean a better outcome'}, {'measure': 'OHIP-14', 'timeFrame': 'Baseline, Day 7, Day 14 after gingivectomy', 'description': 'Improvement in Oral Health Impact Profile (OHIP-14) ; lower scores mean a better outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival Overgrowth', 'Hyaluronic Acid', 'I-PRF', 'T-PRF', 'Gingivectomy'], 'conditions': ['Gingival Overgrowth']}, 'descriptionModule': {'briefSummary': '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.\n\nMaterials 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.', 'detailedDescription': '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.\n\nGingival 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.\n\nA total of four groups were planned in the study: one control group and three test groups.\n\n* Test Group 1: Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing.\n* Test Group 2: Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing.\n* 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.\n* Control Group: Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials.\n\nClinical 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).\n\nConventional 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).\n\nAfter 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).\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18-65 years of age\n2. Being systemically healthy\n3. Having chronic inflammatory gingival overgrowth in the mandibular and maxillary anterior region, with no attachment and bone loss\n4. Not to have used any medication in the last three months\n5. Not smoking\n6. At least 20 natural teeth\n\nExclusion Criteria:\n\n1. Patients with orthodontic appliances\n2. Patients with removable (partial) prostheses\n3. 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\n4. Patients with oral and/or peri-oral pain\n5. Patients with significant oral lesions\n6. Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding\n7. Patients who have undergone periodontal treatment within the last 6 months\n8. Patients with poor communication skills\n9. Smokers and alcohol users'}, 'identificationModule': {'nctId': 'NCT06865092', 'briefTitle': 'Comparison of I-PRF, T-PRF, and 0.8% Hyaluronic Acid Applications in Wound Healing After Gingivectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'OSATAGUN3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '•I-PRF Group', 'description': 'Following gingivectomy with the conventional method (#15 scalpel), I-PRF is applied to the wound site and covered with periodontal dressing.', 'interventionNames': ['Biological: injectable platelet-rich fibrin']}, {'type': 'EXPERIMENTAL', 'label': '• T-PRF Group', 'description': 'Following gingivectomy with the conventional method, T-PRF is applied to the wound site and covered with periodontal dressing.', 'interventionNames': ['Biological: titanium-prepared platelet-rich fibrin']}, {'type': 'EXPERIMENTAL', 'label': '•HA Group', 'description': 'Following gingivectomy with the conventional method, 0.8% HA (Gengigel; Ricerfarma, Milan, Italy) is applied to the wound site and covered with periodontal dressing.', 'interventionNames': ['Drug: Hyaluronic Acid (HA)']}, {'type': 'EXPERIMENTAL', 'label': '•Control Group', 'description': ': Following gingivectomy with the conventional method, the wound site is covered only with periodontal dressing, without additional biomaterials.', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'injectable platelet-rich fibrin', 'type': 'BIOLOGICAL', 'otherNames': ['i-prf'], 'description': '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.', 'armGroupLabels': ['•I-PRF Group']}, {'name': 'titanium-prepared platelet-rich fibrin', 'type': 'BIOLOGICAL', 'otherNames': ['t-prf'], 'description': '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.', 'armGroupLabels': ['• T-PRF Group']}, {'name': 'Hyaluronic Acid (HA)', 'type': 'DRUG', 'otherNames': ['HA', '0.8% HA'], 'description': '0.8% hyaluronic acid (HA) gel (Gengigel) was applied to the wound sites.', 'armGroupLabels': ['•HA Group']}, {'name': 'control group', 'type': 'OTHER', 'description': 'Nothing has applied.', 'armGroupLabels': ['•Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'özlem saraç atagün, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof. Dr.', 'investigatorFullName': 'Özlem SARAÇ ATAGÜN', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}