Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT07207668
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2025-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
i-PRF & Root Surface Biomodification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010514', 'term': 'Periodontal Pocket'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043309', 'term': 'proliferation regulatory factors, human urine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants were blinded to group allocation; however, investigators and outcome assessors were not blinded due to the surgical nature of the interventions.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a single-center, randomized, parallel-group trial. Both groups received open flap debridement with 24% EDTA root surface conditioning. In the test group, injectable platelet-rich fibrin (i-PRF) was additionally applied to the surgical sites, whereas in the control group no i-PRF was used. The only difference between groups was the adjunctive use of i-PRF.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-10-02', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in probing pocket depth (mm) at treated sites', 'timeFrame': 'Baseline and 6 months post-surgery', 'description': 'Measured with a UNC-15 periodontal probe at treated sites.'}], 'secondaryOutcomes': [{'measure': 'Change in clinical attachment level (mm) at treated sites', 'timeFrame': 'Baseline and 6 months post-surgery', 'description': 'Measured with a UNC-15 periodontal probe.'}, {'measure': 'Mean Plaque Index (Silness and Löe Index, 0-3 scale)', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Full-mouth plaque scores (0 = no plaque, 3 = abundant plaque). Higher scores indicate worse oral hygiene.'}, {'measure': 'Mean Gingival Index (Löe and Silness Index, 0-3 scale)', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Gingival inflammation scores (0 = normal gingiva, 3 = severe inflammation). Higher scores indicate worse gingival condition.'}, {'measure': 'Percentage of sites with bleeding on probing (%)', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Assessed by gentle probing (0 = no bleeding, 1 = bleeding present). Higher percentages indicate worse periodontal condition.'}, {'measure': 'Change in gingival recession depth (mm) at treated sites', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Measured vertically from the cemento-enamel junction (CEJ) to the gingival margin using a periodontal probe.'}, {'measure': 'Change in gingival recession width (mm) at treated sites', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'Measured horizontally at the CEJ level using a periodontal probe.'}, {'measure': 'Visual Analog Scale (VAS, 0-10) scores for pain and sensitivity', 'timeFrame': 'Immediately after surgery, Week 1, and Week 2', 'description': 'Patient-reported outcomes (0 = no pain/sensitivity, 10 = worst imaginable). Higher scores indicate worse symptoms.'}, {'measure': 'Clinical healing parameters (edema, erythema, necrosis)', 'timeFrame': 'Week 1, Week 2, and 1 month post-surgery', 'description': 'Presence or absence assessed by clinical inspection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open Flap Debridement (OFD)', 'Pro-angiogenic agents', 'Growth differentiation factors', 'Immunomodulation', 'Ethylenediaminetetraacetic Acid (EDTA)', 'Periodontitis', 'Periodontal Pocket', 'Root Surface Conditioning', 'Platelet-Rich Fibrin', 'Autologous Blood Transfusion'], 'conditions': ['Chronic Periodontitis (Disorder)', 'Periodontitis']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate a new method to improve healing in patients with gum disease (periodontitis). A total of 42 adults with gum pockets deeper than 5 millimeters will take part. All patients will undergo flap surgery, which is a standard treatment for gum disease. Half of the patients will also receive an additional treatment with injectable platelet-rich fibrin (i-PRF), made from their own blood, together with root surface cleaning using EDTA gel. Patients will be followed for 6 months. The study will measure changes in gum pocket depth, gum attachment to teeth, and healing.', 'detailedDescription': 'Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues. Open flap debridement (OFD) is a standard surgical approach for the management of deep periodontal pockets. Injectable platelet-rich fibrin (i-PRF) is an autologous, anticoagulant-free platelet concentrate prepared with low-speed centrifugation and characterized by a fibrin network that gradually releases growth factors. Neutral-pH 24% EDTA root-surface conditioning is used to remove the smear layer and expose collagen, which may support early cell attachment and the adsorption of bioactive molecules.\n\nThis single-center, randomized, parallel-group, open-label clinical trial is designed to evaluate whether the adjunctive use of i-PRF after EDTA root conditioning provides additional benefits compared with EDTA conditioning alone. Adults with periodontitis will be enrolled at a university periodontal clinic and randomized to one of two groups:\n\nControl group: OFD with 24% EDTA gel conditioning (3 minutes)\n\nTest group: OFD with 24% EDTA gel conditioning (3 minutes) followed by application of i-PRF retained on defect surfaces for 5 minutes\n\nA mixed defect model (sites with both intrabony and horizontal components) will be included to reflect real-world clinical presentations.\n\nAll participants will receive standardized Phase I therapy before surgery. On the day of surgery, an antiseptic rinse will be performed, local anesthesia will be administered, full-thickness flaps will be elevated, and meticulous debridement/root planing will be completed. In the test arm, i-PRF will be prepared from venous blood collected into plain glass tubes and centrifuged at \\~700 rpm (60 g) for 3 minutes; the platelet-rich upper layer (\\~1-1.5 mL per tube) will be aspirated and applied to the defect for 5 minutes before primary closure with 4-0 monofilament sutures. Postoperative care will include analgesic and/or anti-inflammatory medication as needed and an antiseptic mouthwash; systemic antibiotics will not be routinely prescribed. Sutures will be removed at approximately 1 week. A planned follow-up schedule will include weekly visits during the first month and monthly visits thereafter through month 6.\n\nThe primary outcome will be the change in probing pocket depth (PPD) at surgical sites at 6 months. Key secondary outcomes will include clinical attachment level (CAL), plaque and gingival indices, bleeding on probing, gingival recession depth and width, patient-reported pain and sensitivity (VAS), and postoperative clinical healing parameters such as edema, erythema, and necrosis, assessed at prespecified time points. Randomization will be computer-generated; surgeries and measurements will be performed by an experienced periodontist using calibrated probes.\n\nThe study has been approved by an institutional ethics committee and will be conducted in accordance with the Declaration of Helsinki and good clinical practice principles. The trial does not involve any U.S. FDA-regulated drug or device. An independent data monitoring committee will not be convened given the low-risk, single-center nature of the interventions; adverse events will be actively assessed at follow-up visits, and participants may withdraw at any time without penalty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Diagnosis of Stage II-IV periodontitis\n* Presence of ≥3 adjacent teeth with probing pocket depth (PPD) ≥5 mm\n* Systemically healthy individuals\n* Non-smokers\n* Ability and willingness to comply with oral hygiene instructions and study follow-up visits\n\nExclusion Criteria:\n\n* Systemic diseases or conditions affecting periodontal healing (e.g., uncontrolled diabetes, immunodeficiency)\n* Pregnancy or lactation\n* Current or previous smokers\n* Use of medications that may affect periodontal status (e.g., immunosuppressants, bisphosphonates)\n* Previous periodontal treatment within the last 6 months'}, 'identificationModule': {'nctId': 'NCT07207668', 'acronym': 'iPRF-Perio', 'briefTitle': 'i-PRF & Root Surface Biomodification', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Effectiveness of Injectable Platelet Rich Fibrin Used For Root Surface Biomodification On Clinical Periodontal Parameters', 'orgStudyIdInfo': {'id': 'GÜDHKAEK.2022.24/2'}, 'secondaryIdInfos': [{'id': 'GÜDHKAEK.2022.24/2', 'type': 'REGISTRY', 'domain': 'Gazi University Faculty of Dentistry Clinical Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control - OFD + EDTA', 'description': 'Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning only. No injectable platelet-rich fibrin (i-PRF) was applied.', 'interventionNames': ['Procedure: Open Flap Debridement (OFD)', 'Other: 24% EDTA Root Conditioning']}, {'type': 'EXPERIMENTAL', 'label': 'Test - OFD + EDTA + i-PRF', 'description': 'Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning plus application of injectable platelet-rich fibrin (i-PRF) to the surgical sites before flap closure.', 'interventionNames': ['Procedure: Open Flap Debridement (OFD)', 'Other: 24% EDTA Root Conditioning', 'Biological: Injectable Platelet-Rich Fibrin (i-PRF)']}], 'interventions': [{'name': 'Open Flap Debridement (OFD)', 'type': 'PROCEDURE', 'otherNames': ['Periodontal Flap Surgery'], 'description': 'Standard periodontal surgical procedure involving full-thickness flap elevation, scaling, and root planing to eliminate inflamed tissue and reduce periodontal pocket depth.', 'armGroupLabels': ['Control - OFD + EDTA', 'Test - OFD + EDTA + i-PRF']}, {'name': '24% EDTA Root Conditioning', 'type': 'OTHER', 'otherNames': ['Ethylenediaminetetraacetic Acid Gel'], 'description': 'Application of 24% neutral pH EDTA gel for 3 minutes on root surfaces to remove the smear layer and expose collagen fibers before closure.', 'armGroupLabels': ['Control - OFD + EDTA', 'Test - OFD + EDTA + i-PRF']}, {'name': 'Injectable Platelet-Rich Fibrin (i-PRF)', 'type': 'BIOLOGICAL', 'otherNames': ['Autologous Injectable PRF'], 'description': 'Autologous platelet concentrate prepared by low-speed centrifugation of venous blood (\\~700 rpm, 3 minutes). The upper plasma fraction rich in platelets and leukocytes was aspirated and applied to defect surfaces for approximately 5 minutes before flap closure.', 'armGroupLabels': ['Test - OFD + EDTA + i-PRF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06590', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University Faculty of Dentistry, Department of Periodontology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'HALİL A BIÇAKÇIOĞLU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Periodontology, Faculty of Dentistry, Gazi University, Ankara, Turkey'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to patient privacy considerations and institutional restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Halil Ata BIÇAKÇIOGLU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, PhD, Department of Periodontology, Gazi University Faculty of Dentistry', 'investigatorFullName': 'Halil Ata BIÇAKÇIOGLU', 'investigatorAffiliation': 'Gazi University'}}}}