Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT06099834
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Osseointegration Process of Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-02', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RFA measurement', 'timeFrame': 'the 1st (T1), 4th (T4), and 12th (T12) weeks', 'description': 'two SmartPeg transducers were used on each implant, and three measurements were completed: therefore, total number of registers was six for each implant. All assessment was carried out consecutively regardless register time or location. Measurements were completed by one only experienced dentist with knowl- edge of the Osstell ISQ system for RFA assessment'}, {'measure': 'Periotest measurement', 'timeFrame': 'the 1st (T1), 4th (T4), and 12th (T12) weeks', 'description': 'The periotest device is placed in a horizontal position 0.6-2 mm away from the tooth surface and two PTVs (PTV1 and PTV2) were calculated with a time difference of 20 min. During each measurement, the device delivers 16 impacts in 4 s to the object.'}], 'secondaryOutcomes': [{'measure': 'Pocket probing depth', 'timeFrame': 'he 1st (T1), 4th (T4), and 12th (T12) weeks', 'description': 'Measurement of the depth of a sulcus or periodontal pocket determined by measuring distance from a gingival margin to the base of the sulcus or pocket with a calibrated periodontal probe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osseointegration', 'dental implant', 'mobility'], 'conditions': ['Dental Implant Failed', 'Osseointegration Failure of Dental Implant']}, 'referencesModule': {'references': [{'pmid': '19405177', 'type': 'BACKGROUND', 'citation': 'Abrahamsson I, Linder E, Lang NP. Implant stability in relation to osseointegration: an experimental study in the Labrador dog. Clin Oral Implants Res. 2009 Mar;20(3):313-8. doi: 10.1111/j.1600-0501.2008.01646.x.'}, {'pmid': '356184', 'type': 'BACKGROUND', 'citation': 'Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.'}, {'pmid': '18379449', 'type': 'BACKGROUND', 'citation': 'Boronat Lopez A, Balaguer Martinez J, Lamas Pelayo J, Carrillo Garcia C, Penarrocha Diago M. Resonance frequency analysis of dental implant stability during the healing period. Med Oral Patol Oral Cir Bucal. 2008 Apr 1;13(4):E244-7.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/22669155/', 'label': 'for discussion'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837777/', 'label': 'for discussion'}]}, 'descriptionModule': {'briefSummary': 'Implant stability is critical to successful osseointegration, the direct structural connection between the dental implant surface and bone. Implant stability must therefore be measured to evaluate implant success. The study evaluated the osseointegration of different sizes with two devices measuring stability with different methods.', 'detailedDescription': 'The 39 implants, 4.0 and 4.5 mm in diameter and 10 and 12 mm in length, in 19 patients were included. Hounsfield unit (HU) values obtained on cone beam computed tomography (CBCT) were recorded. Stabilities were measured with Periotest and resonance frequency analysis (RFA) at day 0 (intra-operative) and the 1st (T1), 4th (T4), and 12th (T12) weeks. Probing depth (PD) and bleeding on probing (BOP) scores were compared between T1 and T4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Absence of any systemic disease\n* being older than 20 years of age\n* having partial tooth deficiency in the posterior region of the lower jaw (molar tooth deficiency)\n* having an indication for dental implant-supported fixed prosthesis\n* at least 6 months had elapsed since the last tooth extraction in the area to be implanted\n* having a soft tissue thickness of at least 1.5 mm and adherent gingival width of at least 2 mm\n* the existence of panoramic and dental volumetric tomography images of the area to be implanted\n* the presence of a suitable recipient bone for implantation with dental implants of the desired length and diameter\n* completion of periodontal treatment and provision of oral hygiene training; and acceptable existing gingival health and oral hygiene for implant application (periodontally healthy) in the oral examinations performed following periodontal treatment.\n\nExclusion Criteria:\n\n* being in American Society of Anesthesiologists (ASA) Class 3 or 4 according to the ASA Physical Status Classification System'}, 'identificationModule': {'nctId': 'NCT06099834', 'briefTitle': 'Evaluation of Osseointegration Process of Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'Evaluation of Osseointegration Process of Implants With Different Length And Diameter By Different Methods', 'orgStudyIdInfo': {'id': '256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient selection', 'description': 'Patient selection criteria were as follows: absence of any systemic disease; not being in American Society of Anesthesiologists (ASA) Class 3 or 4 according to the ASA Physical Status Classification System (Doyle, 2017); being older than 20 years of age; the existence of panoramic and dental volumetric tomography images of the area to be implanted; the presence of a suitable recipient bone for implantation with dental implants of the desired length and diameter.', 'interventionNames': ['Other: Patients selection']}, {'type': 'OTHER', 'label': 'Dental Implant Application', 'description': 'Bredent SKY® dental implants were applied at a torque level of 30 N.cm as recommended by the manufacturer. The surgery and all measurements were performed by the same surgeon.', 'interventionNames': ['Other: Implnat placement']}, {'type': 'OTHER', 'label': 'Osseointegration and periodontal measurements', 'description': "Following the operations, the stability of the dental implants was measured at the 1st (T1), 4th (T4), and 12th (T12) weeks using Periotest (Periotest M, Modautal/Germany) and Osstell (Osstell AB-W\\&H, Sweden) devices. In accordance with the manufacturers' recommendations, the final implant stability quotient (ISQ) and Periotest values were determined by calculating the average of three measurements per implant. At the same time, periodontal index values of probing depth (PD-mm) and bleeding on probing (BOP-%) were recorded at the site of the dental implant at T4 and T12.", 'interventionNames': ['Other: Recall visits']}], 'interventions': [{'name': 'Patients selection', 'type': 'OTHER', 'description': 'Patient selection were selected according to selected criteria.', 'armGroupLabels': ['Patient selection']}, {'name': 'Implnat placement', 'type': 'OTHER', 'description': 'dental implants were applied as recommended by the manufacturer.', 'armGroupLabels': ['Dental Implant Application']}, {'name': 'Recall visits', 'type': 'OTHER', 'description': 'Following the operations, the stability of the dental implants was measured at the 1st (T1), 4th (T4), and 12th (T12) weeks using Periotest (Periotest M, Modautal/Germany) and Osstell (Osstell AB-W\\&H, Sweden) devices.', 'armGroupLabels': ['Osseointegration and periodontal measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34083', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University, School of Dentistry', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Prof Dr', 'investigatorFullName': 'Nur Balci, DDs, PhD', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}