Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-29 @ 7:56 AM
Study NCT ID:
NCT00807456
Status:
COMPLETED
Last Update Posted:
2022-11-17
First Post:
2008-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalResearchMolndal@dentsplysirona.com', 'phone': '+46313763500', 'title': 'Manager Global Clinical Affairs', 'organization': 'DENTSPLY Implants'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 years post implant placement', 'eventGroups': [{'id': 'EG000', 'title': 'ASTRA TECH Implant System, OsseoSpeed™ Profile', 'description': 'ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 0, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Melanoma', 'notes': 'Skin cancer left ring finger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Treated With OsseoSpeed™ Profile Implant', 'description': 'ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 16 weeks', 'description': 'Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Per-protocol analysis set'}, {'type': 'SECONDARY', 'title': 'Implant Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}, {'units': 'Implants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Assessed at Permanent Restoration 21 Weeks Post Implant Placement', 'description': 'Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}, {'id': 'OG001', 'title': 'Subjects Assessed at 12 Months Post Implant Placement', 'description': 'Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}, {'id': 'OG002', 'title': 'Subjects Assessed at 24 Months Post Implant Placement', 'description': 'Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}, {'id': 'OG003', 'title': 'Subjects Assessed at 36 Months Post Implant Placement', 'description': 'Subjects treated with ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '21 weeks, 12 months, 24 months and 36 months post implant placement.', 'description': 'The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal.', 'unitOfMeasure': 'Implants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Per-protocol analysis set'}, {'type': 'SECONDARY', 'title': 'Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Treated With OsseoSpeed™ Profile Implant', 'description': 'ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}], 'classes': [{'title': 'Implant Placement to re-entry (implant placement + 16 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Implant placement to permanent restoration (implant placement + 21 weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Implant placement to implant placement + 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Implant placement to implant placement + 36 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '1.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement', 'description': 'MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Per-protocol analysis set. All subjects/implants available for each visit are included in below analyses.'}, {'type': 'SECONDARY', 'title': 'Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Treated With OsseoSpeed™ Profile Implant', 'description': 'ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}], 'classes': [{'title': 'Permanent restoration 21 weeks after implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '12 months after implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': '24 months after implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': '36 months after implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 weeks, 12 months, 24 months, and 36 months post implant placement', 'description': 'BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site.', 'unitOfMeasure': 'Implants with BoP', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Per-protocol analysis set. All subjects available for each visit are included in below analyses.'}, {'type': 'SECONDARY', 'title': 'Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Treated With OsseoSpeed™ Profile Implant', 'description': 'ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}], 'classes': [{'title': 'Permanent restoration to 12 months post implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'Permanent restoration to 24 months post implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Permanent restoration to 36 months post implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months, 24 months, and 36 months post implant placement', 'description': 'PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level.', 'unitOfMeasure': 'PPD in mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Per-protocol analysis set. All subjects available for each visit are included in below analyses.'}, {'type': 'SECONDARY', 'title': 'Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Treated With OsseoSpeed™ Profile Implant', 'description': 'ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}], 'classes': [{'title': 'Permanent restoration to 12 months post implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Permanent restoration to 24 months post implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Permanent restoration to 36 months post implant placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}, {'units': 'Implants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 months, 24 months, and 36 months post implant placement', 'description': 'CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level.', 'unitOfMeasure': 'CAL in mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Per-protocol analysis set. All subjects available for each visit are included in below analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects Treated With OsseoSpeed™ Profile Implant', 'description': 'ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'Surgical Re-entry (Implant Placement + 16-17 Weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Treated With ASTRA TECH Implant System, OsseoSpeed™ Profile Implant', 'description': 'ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.05', 'spread': '13.974', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-03', 'studyFirstSubmitDate': '2008-12-11', 'resultsFirstSubmitDate': '2016-03-16', 'studyFirstSubmitQcDate': '2008-12-11', 'lastUpdatePostDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-26', 'studyFirstPostDateStruct': {'date': '2008-12-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement', 'timeFrame': 'At baseline and 16 weeks', 'description': 'Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.'}], 'secondaryOutcomes': [{'measure': 'Implant Survival Rate', 'timeFrame': '21 weeks, 12 months, 24 months and 36 months post implant placement.', 'description': 'The survival rate for individual implants was evaluated at each visit. Any removed implant was considered an implant loss, regardless of reason for removal.'}, {'measure': 'Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level', 'timeFrame': 'Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement', 'description': 'MBL alteration assessed by measuring the distance from the implant reference point to the most conical bone-to-implant contact on the mesial and distal side of the implant. The mean of all values for one subject was calculated and used for analysis.'}, {'measure': 'Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)', 'timeFrame': '21 weeks, 12 months, 24 months, and 36 months post implant placement', 'description': 'BoP was assessed by recording bleeding after probing at the mesial, distal, buccal, and palatal surfaces of the implant site.'}, {'measure': 'Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration', 'timeFrame': 'Baseline and 12 months, 24 months, and 36 months post implant placement', 'description': 'PPD was measured using a regular peridontal probe from the gingival margin to nearest whole millimeter. The average PPD change from permanent restoration is presented on implant level.'}, {'measure': 'Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration', 'timeFrame': 'Baseline and 12 months, 24 months, and 36 months post implant placement', 'description': 'CAL was measure with a probe from the crown margin (the interface between the abutment) to the crown at the mesial, buccal, distal, and lingual aspects of the implant. The average CAL change from permanent restoration is presented on implant level.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Edentulism']}, 'referencesModule': {'references': [{'pmid': '23210667', 'type': 'RESULT', 'citation': 'Noelken R, Donati M, Fiorellini J, Gellrich NC, Parker W, Wada K, Berglundh T. Soft and hard tissue alterations around implants placed in an alveolar ridge with a sloped configuration. Clin Oral Implants Res. 2014 Jan;25(1):3-9. doi: 10.1111/clr.12079. Epub 2012 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.\n\nThe hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* Aged 18-75 years at enrolment\n* A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site\n* History of edentulism in the study area of at least 3 months\n* Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement.\n* In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position)\n* Deemed by the investigator as likely to present an initially stable implant situation\n\nExclusion Criteria:\n\n* Uncontrolled pathological processes in the oral cavity\n* Known or suspected current malignancy\n* History of radiation therapy in the head and neck region\n* History of chemotherapy within 5 years prior to surgery\n* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration\n* Uncontrolled diabetes mellitus\n* Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration\n* Smoking more than 10 cigarettes per day\n* Present alcohol and/or drug abuse\n* Current need for bone grafting in the planned implant area\n* Previous enrolment in the present study\n* Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months\n* Involvement in the planning and conduct of the study (applies to both Sponsor staff or staff at the study site)\n* Unlikely to be able to comply with study procedures, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT00807456', 'briefTitle': 'Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dentsply Sirona Implants and Consumables'}, 'officialTitle': 'A Prospective, Open, Single Arm, Multi-center Study to Evaluate Maintenance of Lingual Bone in Healed Ridges With the ASTRA TECH Implant System, OsseoSpeed™ Profile Implant. A 3-year Follow-up Study', 'orgStudyIdInfo': {'id': 'YA-PRO-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant', 'interventionNames': ['Device: ASTRA TECH Implant System, OsseoSpeed™']}], 'interventions': [{'name': 'ASTRA TECH Implant System, OsseoSpeed™', 'type': 'DEVICE', 'description': 'ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.', 'armGroupLabels': ['Subjects treated with ASTRA TECH Implant System, OsseoSpeed™ Profile implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33328-2018', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Department of Periodontology, College of Dental Medicine, Nova Southeastern University', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Department of Periodontics, Robert Schattner Center, School of Dental Medicine, University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'D-30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-88131', 'city': 'Lindau', 'country': 'Germany', 'facility': 'Praxis Dr Robert Nölken', 'geoPoint': {'lat': 47.54612, 'lon': 9.68431}}, {'zip': 'IT-06121', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Studio Dentistico Donati', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}], 'overallOfficials': [{'name': 'Tord Berglundh, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Periodontology, Sahlgrenska Academy at University of Gothenburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dentsply Sirona Implants and Consumables', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}