Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-12 @ 9:21 AM
Study NCT ID:
NCT02349620
Status:
UNKNOWN
Last Update Posted:
2015-01-29
First Post:
2014-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Platelet-rich Factor on Implant Stability and Bone Resorption in the Lower Posterior Mandible
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2014-10-05', 'studyFirstSubmitQcDate': '2015-01-23', 'lastUpdatePostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant loss', 'timeFrame': '6 months', 'description': 'During the osseointegration, if the implant lose his stability and if the patient have pain, the implant will be removed and the implant will be considered lost'}], 'secondaryOutcomes': [{'measure': 'ISQ analysis', 'timeFrame': '3 months', 'description': 'Since the implant installation, the implant stability will be measure with the Osstell, that will return a number between 0 and 100. This represents the Implant Stability Quotient (ISQ). The difference between the ISQ results will be the secondary outcome measure'}, {'measure': 'bone height (mm)', 'timeFrame': '6 months', 'description': 'Since the implant insertion , bone height was measured in mesial and distal side on standardized IOPA x-ray'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osseointegrated Dental Implantation']}, 'descriptionModule': {'briefSummary': 'The main objective of this clinical trial study is to consider the effect of Platelet-Rich-Factor (PRF) on implant stability and marginal bone resorption around dental implants.', 'detailedDescription': 'Dental implants were placed in 30 subjects who have 1 or 2 missing teeth in both side of posterior mandible. Implants with a length of 11.5 and a diameter of 4.5 mm will be inserted in both sides. In one side PRF will be instilled after surface treatment with PRF before implant placement, while no PRF was added in other side to serve as control group. All implants will be followed with stability measurement by means of resonance frequency analysis at baseline, and every two weeks up to 3 months. Bone height was measured on medial \\& distal side on standardized IOPA x-rays.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have 1 or 2 missing teeth in both side of posterior mandible\n\n * adequate bone quantity and quality at the implant site\n * the implant sites with at least 3 months of healing after extraction,\n * patients well motivated for implant therapy and maintaining good oral hygiene\n * the implant sites with width and length to installation of an implant of 4.5 mm x 11.5 mm.\n * Patients who gave written informed consent\n\nExclusion Criteria:\n\n* • medically compromised or patients taking any immunosuppressive drugs which may complicate the treatment outcome\n\n * infection around the implant site\n * history of bruxism/parafunctional habits\n * patients with history of any bleeding disorder or on anti-coagulant therapy.\n * pregnant patients'}, 'identificationModule': {'nctId': 'NCT02349620', 'briefTitle': 'Effect of Platelet-rich Factor on Implant Stability and Bone Resorption in the Lower Posterior Mandible', 'organization': {'class': 'OTHER', 'fullName': 'Shiraz University of Medical Sciences'}, 'officialTitle': 'Platelet-rich Factot in Implant Dentistry', 'orgStudyIdInfo': {'id': '123456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A:partialy edutolus patients', 'description': 'In this group surface treated implant with PRF will be inserted.Immediately after the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequency analysis (RFA), using the smart peg type 1, then stability will be measured every 2 weeks up to 3 months .Bone height will be measured in mesial and distal side immediately after placement and in months 3 and 6 with Intra Oral Peri Apical xray (IOPA x-ray)', 'interventionNames': ['Biological: PRF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B: partialy edutolus patients', 'description': 'In this group implant with out PRF will be inserted.Immediately after the surgery the implant stability will be measured with the Osstell mentor to verify the resonance frequence analysis (RFA ), using the smartpeg type 1, then stability will be measured every 2 weeks up to 3 months. Bone height was measured in mesial and distal side immediately after placement and in months 3 and 6 with IOPA xray'}], 'interventions': [{'name': 'PRF', 'type': 'BIOLOGICAL', 'description': 'implant stability was measured by RFA and implant resorption was measured by IOPA after surface treatment by PRF', 'armGroupLabels': ['A:partialy edutolus patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Reza Tabrizi, DMD', 'role': 'CONTACT', 'email': 'tabmed@gmail.com', 'phone': '989125850829'}, {'name': 'Touba Karagah, DMD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Reza Tabrizi, DMD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shiraz university of medical sciences', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}], 'centralContacts': [{'name': 'Reza Tabrizi, DMD', 'role': 'CONTACT', 'email': 'Tabmed@gmail.com', 'phone': '09125850829'}], 'overallOfficials': [{'name': 'Reza Tabrizi, DMD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shiraz University of Medical Sciences'}, {'name': 'Touba karagah, DMD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shiraz University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reza Tabrizi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of shahid beheshti university of medical sciences', 'investigatorFullName': 'Reza Tabrizi', 'investigatorAffiliation': 'Shiraz University of Medical Sciences'}}}}