Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2026-01-24 @ 9:56 AM
Study NCT ID:
NCT02733861
Status:
UNKNOWN
Last Update Posted:
2018-06-14
First Post:
2016-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Related Factors Influencing the Stability of Dental Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-12', 'studyFirstSubmitDate': '2016-03-29', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant stability quotient (ISQ) was tested by Osstell™ Mentor', 'timeFrame': 'on the day of surgery', 'description': 'The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ.'}, {'measure': 'Implant stability quotient (ISQ) was tested by Osstell™ Mentor', 'timeFrame': 'on the 12th weeks after surgery', 'description': 'The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ.'}], 'secondaryOutcomes': [{'measure': 'Measure the bone density of the implant locations by CBCT.', 'timeFrame': 'within 10 days before surgery', 'description': 'Using the interactive setting on the SimplantTM software, an implant was then placed over the alveolar portion of each edentulous span to include the trabecular portion and the outer cortical shell when present. The computer was then asked to map the density of the bone around the entire circumference of each implant, with a surrounding thickness of 1 mm, which is the default setting . Multiple adjacent readings were taken within each span, where possible. Subsequently, all areas subjectively classified into each of the four qualities were pooled so that a range of Houndsfield values (HU) could be attributed to each particular quality, and a mean value was calculated in order to establish a new objective quantitative scale of bone density.'}, {'measure': 'Measure the thickness of the bone around the implant by CBCT.', 'timeFrame': 'immediately after the surgery', 'description': 'Using the interactive setting on the SimplantTM software, an implant was then placed over the alveolar portion of each edentulous span to include the trabecular portion and the outer cortical shell when present. The computer was then asked to map the density of the bone around the entire circumference of each implant, with a surrounding thickness of 1 mm, which is the default setting . Multiple adjacent readings were taken within each span, where possible. Subsequently, all areas subjectively classified into each of the four qualities were pooled so that a range of Houndsfield values (HU) could be attributed to each particular quality, and a mean value was calculated in order to establish a new objective quantitative scale of bone density.'}, {'measure': 'Measure the crestal bone resorption by X-ray images', 'timeFrame': 'immediately and 3 months after the surgery', 'description': 'The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental implant', 'stability', 'implant stability quotient'], 'conditions': ['Teeth Missing']}, 'referencesModule': {'references': [{'pmid': '20666788', 'type': 'BACKGROUND', 'citation': 'Merheb J, Van Assche N, Coucke W, Jacobs R, Naert I, Quirynen M. Relationship between cortical bone thickness or computerized tomography-derived bone density values and implant stability. Clin Oral Implants Res. 2010 Jun;21(6):612-7. doi: 10.1111/j.1600-0501.2009.01880.x.'}, {'pmid': '12886205', 'type': 'RESULT', 'citation': 'Goodacre CJ, Bernal G, Rungcharassaeng K, Kan JY. Clinical complications with implants and implant prostheses. J Prosthet Dent. 2003 Aug;90(2):121-32. doi: 10.1016/S0022-3913(03)00212-9.'}, {'pmid': '15747677', 'type': 'RESULT', 'citation': 'Fugazzotto PA. Success and failure rates of osseointegrated implants in function in regenerated bone for 72 to 133 months. Int J Oral Maxillofac Implants. 2005 Jan-Feb;20(1):77-83.'}, {'pmid': '17974108', 'type': 'RESULT', 'citation': 'Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.'}, {'pmid': '20546821', 'type': 'RESULT', 'citation': 'Javed F, Romanos GE. The role of primary stability for successful immediate loading of dental implants. A literature review. J Dent. 2010 Aug;38(8):612-20. doi: 10.1016/j.jdent.2010.05.013. Epub 2010 Jun 11.'}, {'pmid': '15839115', 'type': 'RESULT', 'citation': 'Herrmann I, Lekholm U, Holm S, Kultje C. Evaluation of patient and implant characteristics as potential prognostic factors for oral implant failures. Int J Oral Maxillofac Implants. 2005 Mar-Apr;20(2):220-30.'}, {'pmid': '17168930', 'type': 'RESULT', 'citation': 'Turkyilmaz I, Tozum TF, Tumer C, Ozbek EN. Assessment of correlation between computerized tomography values of the bone, and maximum torque and resonance frequency values at dental implant placement. J Oral Rehabil. 2006 Dec;33(12):881-8. doi: 10.1111/j.1365-2842.2006.01692.x.'}, {'pmid': '19667820', 'type': 'RESULT', 'citation': 'Aksoy U, Eratalay K, Tozum TF. The possible association among bone density values, resonance frequency measurements, tactile sense, and histomorphometric evaluations of dental implant osteotomy sites: a preliminary study. Implant Dent. 2009 Aug;18(4):316-25. doi: 10.1097/ID.0b013e31819ecc12.'}, {'pmid': '20711163', 'type': 'RESULT', 'citation': 'Farre-Pages N, Auge-Castro ML, Alaejos-Algarra F, Mareque-Bueno J, Ferres-Padro E, Hernandez-Alfaro F. Relation between bone density and primary implant stability. Med Oral Patol Oral Cir Bucal. 2011 Jan 1;16(1):e62-7. doi: 10.4317/medoral.16.e62.'}, {'pmid': '24384740', 'type': 'RESULT', 'citation': 'Monje A, Suarez F, Garaicoa CA, Monje F, Galindo-Moreno P, Garcia-Nogales A, Wang HL. Effect of location on primary stability and healing of dental implants. Implant Dent. 2014 Feb;23(1):69-73. doi: 10.1097/ID.0000000000000019.'}, {'pmid': '17635248', 'type': 'RESULT', 'citation': 'Turkyilmaz I, Tumer C, Ozbek EN, Tozum TF. Relations between the bone density values from computerized tomography, and implant stability parameters: a clinical study of 230 regular platform implants. J Clin Periodontol. 2007 Aug;34(8):716-22. doi: 10.1111/j.1600-051X.2007.01112.x.'}, {'pmid': '22092387', 'type': 'RESULT', 'citation': 'Hong J, Lim YJ, Park SO. Quantitative biomechanical analysis of the influence of the cortical bone and implant length on primary stability. Clin Oral Implants Res. 2012 Oct;23(10):1193-7. doi: 10.1111/j.1600-0501.2011.02285.x. Epub 2011 Sep 29.'}, {'pmid': '26744262', 'type': 'RESULT', 'citation': 'Calvo-Guirado JL, Lopez-Lopez PJ, Perez-Albacete Martinez C, Javed F, Granero-Marin JM, Mate Sanchez de Val JE, Ramirez Fernandez MP. Peri-implant bone loss clinical and radiographic evaluation around rough neck and microthread implants: a 5-year study. Clin Oral Implants Res. 2018 Jun;29(6):635-643. doi: 10.1111/clr.12775. Epub 2016 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'With the development of oral medicine,dental implants has become a very popular solution to remediate the loss of teeth and dental rehabilitation. For the last few decades, the immediate loading protocol have become more and more popular because the increasing demands of shortened treatment time. Implant stability is considered one of the most important parameters in implant dentistry. It affects the healing and successful osseointegration of implants. For any implant procedure, successful implant integration is a prerequisite criterion, which depends on a series of procedure-related and patient-dependent factors. It also has been considered that preoperative measurement is critical and may give valuable information to predict loading time and survival of the implants.\n\nIn this clinical study, the samples were collected from patients with single teeth missing who came from the department of prosthodontics from the School of Stomatology of the Fourth Military Medical University.The prospective cohort study was used to investigate the correlation between different factors and the early stability of the implants. And then, using the correlation between different factors and the early implant stability gives predictable data about implant stability and then evaluate the accuracy and reliability.', 'detailedDescription': "Ethical and institutional approval was obtained from the study institution. From May 2015 to May 2017, teeth missing consecutive patients requiring implant treatment consented to participate in this study to investigate the correlation between implant stability and bone density.\n\nCone beam computed tomography (CBCT) was used for preoperative radiological evaluation of the jawbone for each patient, and then bone density in Houndsfield units scale was assessed by SimPlant Pro 11.04 software. Immediately after the implant placement and 12 weeks later, stability measurements were performed with Osstell™ Mentor.The captured data was represented in a quantitative unit called Implant Stability Quotient (ISQ) on a scale from 1 to 100 and averaged for each implant.\n\nThe descriptive statistical methods were used to show the differences in bone density and ISQ values among location, gender, age and implant diameter variables. Mann-whitney test was used for comparison of HU values and ISQ values between different age and gender groups. Kruskal-Wallis test was used for comparison of HU values and ISQ values between different location and implant diameter groups. The changes of ISQ values over time were compared using Wilcoxon signed rank test. The Spearman's rank correlation coefficient was used to investigate the correlation between ISQ values and HU values.\n\nAt last, to investigate the possible correlations between implant stability and bone density and to study the feasibility of predicting implant stability by using preoperative CBCT."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'single teeth missing consecutive patients requiring implant treatment consented to participate in this study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the patients who had undergone tooth extraction within the previous 3 months\n\nExclusion Criteria:\n\n* those who required bone augmentation simultaneously with implant insertion, and patients with any systemic disease'}, 'identificationModule': {'nctId': 'NCT02733861', 'briefTitle': 'Evaluation of the Related Factors Influencing the Stability of Dental Implants', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Evaluation of the Related Factors Influencing the Stability of Dental Implants', 'orgStudyIdInfo': {'id': 'IRB-REV-2016012'}}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Dingxin', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Yumei Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of prosthetic dentistry, Stomatology hospital, Fourth Military Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhang Yumei', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}