Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:19 AM
Study NCT ID:
NCT07375004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injectable PRF in Non-Surgical Periodontal Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010514', 'term': 'Periodontal Pocket'}, {'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043309', 'term': 'proliferation regulatory factors, human urine'}, {'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study follows a double-blind protocol regarding outcome assessment and data analysis. The clinical and microbiological examiner (Outcomes Assessor) is masked to the treatment allocation. Furthermore, the statistician (Statistical Investigator) will receive the data in a coded format (e.g., Side A and Side B) without knowing which side received the i-PRF intervention until the final analysis is completed'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a split-mouth randomized controlled trial. Each participant receives both treatments in different quadrants of the mouth. One quadrant is randomly assigned to the intervention (Scaling and Root Planing + i-PRF) and the contralateral quadrant serves as the control (Scaling and Root Planing alone)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Probing Pocket Depth (PPD)', 'timeFrame': 'Baseline, 1 month, and 3 months post-intervention', 'description': "Probing pocket depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a standardized periodontal probe (e.g., William's probe) at six sites per tooth."}], 'secondaryOutcomes': [{'measure': 'Clinical Attachment Level (CAL)', 'timeFrame': 'Baseline, 1 month, and 3 months post-intervention', 'description': 'Measurement of the distance from the cemento-enamel junction (CEJ) to the base of the periodontal pocket in millimeters.'}, {'measure': 'Bleeding on Probing (BOP)', 'timeFrame': 'Baseline, 1 month, and 3 months post intervention', 'description': 'Assessment of the presence or absence of bleeding within 30 seconds after probing, recorded as a percentage of total sites.'}, {'measure': 'Plaque Index (PI)', 'timeFrame': 'Baseline, 1 month, and 3 months post intervention .', 'description': "Assessment of the amount of dental plaque on the tooth surfaces to evaluate the patient's oral hygiene during the study."}, {'measure': 'Microbiological Analysis (Bacterial Load)', 'timeFrame': 'Baseline, 1 month, and 3 months post intervention', 'description': 'Quantification of subgingival periodontal pathogens (P. gingivalis and F. nucleatum )using Quantitative Real-time PCR (qPCR) from subgingival plaque samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Injectable Platelet-Rich Fibrin', 'i-PRF', 'Scaling and Root Planing', 'Non-Surgical Periodontal Therapy', 'Split-mouth design', 'Microbiological outcomes', 'Periodontitis', 'Regeneration'], 'conditions': ['Periodontitis', 'Periodontal Pocket', 'Alveolar Bone Loss']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the clinical and microbiological effects of using injectable Platelet-Rich Fibrin (i-PRF) as an adjunct to non-surgical periodontal therapy (scaling and root planing) in patients with periodontitis. The study uses a split-mouth design where one side of the mouth receives the treatment with i-PRF and the other side receives standard treatment alone. Clinical parameters and bacterial counts will be compared at baseline, 1 month, and 3 months after intervention .', 'detailedDescription': 'Patients with periodontitis will be recruited for this split-mouth randomized controlled trial. All participants will receive full-mouth supra and sub-gingival scaling and root planing (SRP). In the intervention side, i-PRF will be injected into the periodontal pockets, while the control side will receive SRP only.\n\nClinical measurements including Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), and Bleeding on Probing (BOP) will be recorded. Additionally, microbiological samples will be collected to assess the changes in the subgingival Porphyromonas gingivalis and Fusobacterium nucleatum . Follow-up visits are scheduled at 1 and 3 months post-intervention to assess the adjunctive benefit of i-PRF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects aged 30 years and above.\n* No history of systemic diseases (e.g., diabetes mellitus).\n* Not currently under active periodontal therapy or joining other trial in the last 3 months.\n* Diagnosis with Stage II or III Periodontitis.\n* presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD \\>4mm at ≥2 teeth.\n\nExclusion Criteria:\n\n* Smokers or alcohol users.\n* Patients consuming antibiotics or anticoagulants.\n* Regular users of non-steroidal anti-inflammatory drugs.\n* Receipt of periodontal treatment within 3 months prior to the study.\n* Any bleeding or clotting disorders.\n* Teeth with Grade II or Grade III furcation involvement.\n* Pregnant or breastfeeding mothers.\n* Patients unwilling to participate.'}, 'identificationModule': {'nctId': 'NCT07375004', 'acronym': 'IPRF-PERIO', 'briefTitle': 'Injectable PRF in Non-Surgical Periodontal Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Al-Mustansiriyah University'}, 'officialTitle': 'Adjunctive Use of Injectable PRF in Non-surgical Periodontal Therapy: Clinical and Microbiological Outcomes ( Split - Mouth Randomized Controlled Trial )', 'orgStudyIdInfo': {'id': 'UOM-DENT-ETHIC-2026-042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: i-PRF + SRP', 'description': 'This quadrant of the mouth will receive full-mouth scaling and root planing (SRP) followed by the subgingival injection of injectable Platelet-Rich Fibrin (i-PRF) into the periodontal pockets', 'interventionNames': ['Biological: Injectable Platelet-Rich Fibrin (i-PRF).', 'Procedure: Scaling and Root Planing (SRP).']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: SRP Alone', 'description': 'This contralateral quadrant of the mouth will receive full-mouth scaling and root planing (SRP) only, serving as the control side to compare with the i-PRF intervention.', 'interventionNames': ['Procedure: Scaling and Root Planing (SRP).']}], 'interventions': [{'name': 'Injectable Platelet-Rich Fibrin (i-PRF).', 'type': 'BIOLOGICAL', 'otherNames': ['Autologous Platelet Concentrate.', 'i-PRF'], 'description': 'Ten ml of whole blood is collected from the participant into plain tubes and immediately centrifuged. The centrifugation protocol follows the low-speed concept (e.g., 700 rpm for 3 minutes). The upper orange-colored liquid (i-PRF) is then collected and injected subgingivally into the periodontal pockets using a 25-gauge needle immediately after scaling and root planing', 'armGroupLabels': ['Experimental: i-PRF + SRP']}, {'name': 'Scaling and Root Planing (SRP).', 'type': 'PROCEDURE', 'otherNames': ['Non surgical periodontal therapy', 'SRP', 'Initial periodontal therapy', 'Phase I periodontal therapy', 'Cause related periodontal therapy'], 'description': 'Full-mouth non-surgical periodontal therapy including supra and sub-gingival scaling and root planing performed using ultrasonic devices and Gracey curettes to remove dental biofilm and calculus', 'armGroupLabels': ['Active Comparator: SRP Alone', 'Experimental: i-PRF + SRP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Mustansiriyah University, College of Dentistry.', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Mustansiriyah University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master student', 'investigatorFullName': 'Thuraya ayad taher al-jubori', 'investigatorAffiliation': 'Al-Mustansiriyah University'}}}}