Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT06742151
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2024-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Prevalence Rate and Related Risk Factors of Ridge Preservation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057126', 'term': 'Nuclear Receptor Subfamily 4, Group A, Member 2'}], 'ancestors': [{'id': 'D057093', 'term': 'Orphan Nuclear Receptors'}, {'id': 'D004268', 'term': 'DNA-Binding Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018160', 'term': 'Receptors, Cytoplasmic and Nuclear'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reason for tooth extraction', 'timeFrame': 'at the day of implant surgery', 'description': 'due to caries, periodontal disease, tooth fracture, residual root, endodontic failure'}], 'secondaryOutcomes': [{'measure': 'Radiographic analysis', 'timeFrame': 'at the day of implant surgery', 'description': 'with or without apical lesion and with or without marginal bone loss'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alveolar ridge preservation', 'Early implant placement'], 'conditions': ['Dental Implants']}, 'referencesModule': {'references': [{'pmid': '19216285', 'type': 'BACKGROUND', 'citation': 'Ahn JJ, Shin HI. Bone tissue formation in extraction sockets from sites with advanced periodontal disease: a histomorphometric study in humans. Int J Oral Maxillofac Implants. 2008 Nov-Dec;23(6):1133-8.'}, {'pmid': '15691354', 'type': 'BACKGROUND', 'citation': 'Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.'}, {'pmid': '28000278', 'type': 'BACKGROUND', 'citation': 'Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.'}, {'pmid': '15842256', 'type': 'BACKGROUND', 'citation': 'Cardaropoli G, Araujo M, Hayacibara R, Sukekava F, Lindhe J. Healing of extraction sockets and surgically produced - augmented and non-augmented - defects in the alveolar ridge. An experimental study in the dog. J Clin Periodontol. 2005 May;32(5):435-40. doi: 10.1111/j.1600-051X.2005.00692.x.'}, {'pmid': '12956657', 'type': 'BACKGROUND', 'citation': 'Cardaropoli G, Araujo M, Lindhe J. Dynamics of bone tissue formation in tooth extraction sites. An experimental study in dogs. J Clin Periodontol. 2003 Sep;30(9):809-18. doi: 10.1034/j.1600-051x.2003.00366.x.'}, {'pmid': '22211307', 'type': 'BACKGROUND', 'citation': 'Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x.'}]}, 'descriptionModule': {'briefSummary': 'Treated by dental implant is a well document and popular therapy nowadays. Placement of a dental implant in an ideal three-dimensional position is critical in achieving a predictable long-term success. However, healing of an extraction socket involves bone remodeling, which inevitably leads to atrophic changes of the alveolar ridge. Studies have shown that most of the resorption occurs during the first 3 months of healing, although dimensional changes can be observed up to 1 year after tooth extraction, resulting in approximately 50% reduction of the bucco-lingual dimension of the alveolar ridge, mainly due to the resorption of the bundle bone plate.\n\nTherefore, the timing of implant placement in extraction sockets can influence the surgery operability and treatment period of time. The classifications of timing of implant placement in extraction sockets as following: Type I: immediate implant placement: implant placement immediately following tooth extraction and as part of the same surgical procedure. Type II: early implant placement: surgery after complete soft tissue coverage of the socket (typically 4\\~8 weeks).\n\nType III: early implant placement: implant surgery after substantial clinical and/or radiographic bone fill of the socket (typically 12\\~16 weeks). Type IV: late implant placement: surgery at healed site (typically more than 16 weeks). Considering of technique sensitivity and treatment time consuming, early implant placement is the most acceptable clinically.\n\nMany techniques have been developed to maintain the architecture of residual alveolar ridges and regenerative techniques for socket preservation is one of them. This procedure has been widely tested in controlled and uncontrolled studies with various materials and clinical approaches. However, this procedure may require longer treatment period compare to conventional or early implant placement protocol. Meanwhile, there is no study revealed how often and when does socket preservation need to prevent the residual ridge deformity in our daily clinical practice. The aim of the study is try to retrospectively find out the possible advantages and percentage of ridge preservation after tooth extraction in order to understand whether the socket preservation technique is necessary after tooth extraction, and the possible factors which might affect the clinical decision-making.', 'detailedDescription': 'Background:\n\nThe alveolar process is a tooth-dependent tissue that develops in conjunction with the eruption of the teeth. The tooth is anchored to the jaws via the bundle bone into which the periodontal ligament fibers invest. Subsequent to the removal of the tooth, the alveolar process will undergo atrophy. The dynamics and magnitude of these changes have been investigated in the dog model as well as in humans. Most of the resorption occurs during the first 3 months of healing, although dimensional changes can be observed up to 1 year after tooth extraction, resulting in approximately 50% reduction of the bucco-lingual dimension of the alveolar ridge, mainly due to the resorption of the bundle bone plate. Some studies showed that significant loss of tissue contour occurs during the first month after tooth extraction, averaging 3\\~5mm in width at 6 months. As a result, a residual ridge is often inadequate for ideal implant placement, which creating a clinical challenge for the placement of a dental implant in an ideal position. However, placement of a dental implant in an ideal three-dimensional position is critical in achieving a predictable functional and esthetic restoration.\n\nTherefore, the timing of implant placement in extraction sockets can influence the surgery operability and treatment period of time. The classifications of timing of implant placement in extraction sockets as following: Type I: immediate implant placement: implant placement immediately following tooth extraction and as part of the same surgical procedure. Type II: early implant placement: surgery after complete soft tissue coverage of the socket (typically 4\\~8 weeks).Type III: early implant placement: implant surgery after substantial clinical and/or radiographic bone fill of the socket (typically 12\\~16 weeks). Type IV: late implant placement: surgery at healed site (typically more than 16 weeks). Considering of technique sensitivity and treatment time consuming, early implant placement is the most acceptable clinically. However, different treatment strategies may be applied because of the vary amounts of resorption after tooth extraction.\n\nSome of the extraction sockets will heal completely and the implant can be placed in an ideal position 3 months after tooth extraction. Others may require adjunctive surgical procedures (like guided bone regeneration, GBR) during the implant surgery. In some cases, with severe bone resorption after tooth extraction, staged approach for implant placement is recommended due to lack of sufficient bone volume, which is the most time consuming and expensive treatment method.\n\nIn order to avoid this situation, some surgical procedures have been described to prevent alveolar ridge collapsing after tooth extraction, including regenerative techniques for socket preservation and immediate implant placement after tooth extraction. The socket preservation technique has been widely tested in controlled and uncontrolled studies with various materials and clinical approaches. However, this may require longer treatment period compare to early implant placement protocol and so far, there is no study revealed how often and when does socket preservation need to prevent the residual ridge deformity in our daily clinical practice.\n\nPurpose:\n\nThe purpose of this study is to evaluate:\n\n1. How often do the clinical cases require ridge preservation than early implant placement protocol?\n2. Which factors may influence the clinical decision?\n\nHypothesis:\n\nRidge preservation is better than early implant placement protocol.\n\nImportance:\n\nHelp the clinician to make a more precise decision-making.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who plan to have single implant surgery from July 2009 to August 2015 were included in this study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* periapical film at the time of tooth extraction\n* implant surgery was scheduled within 4 months after tooth extraction.\n\nExclusion Criteria:\n\n\\- who cannot identify the reason for tooth extraction or unclear periapical film'}, 'identificationModule': {'nctId': 'NCT06742151', 'briefTitle': 'Evaluation of the Prevalence Rate and Related Risk Factors of Ridge Preservation', 'organization': {'class': 'OTHER', 'fullName': 'Chimei Medical Center'}, 'officialTitle': 'Evaluation of the Prevalence Rate and Related Risk Factors of Ridge Preservation', 'orgStudyIdInfo': {'id': '1 0 3 0 3 - 0 0 5'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patient who received an implant after surgery.', 'interventionNames': ['Procedure: implant can be placed or not']}, {'label': 'Group 2', 'description': "Patient who didn't receive an implant due to insufficient bone volume or implant primary stability for implant placement.", 'interventionNames': ['Procedure: implant can be placed or not']}], 'interventions': [{'name': 'implant can be placed or not', 'type': 'PROCEDURE', 'description': 'the possibility of receiving dental implants', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'CHUNJUNG CHEN, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chimei Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chimei Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Periodontics', 'investigatorFullName': 'CHUNJUNG CHEN', 'investigatorAffiliation': 'Chimei Medical Center'}}}}