Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-02-28 @ 7:33 PM
Study NCT ID:
NCT05283928
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2022-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol
Sponsor:
Organization:
Raw JSON
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The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of implant surgery', 'description': 'bone ridge width will be measured using a Caliper', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'PRIMARY', 'title': 'Change in Bone Ridge Width at 10mm Apical From Crest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. 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The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of implant surgery', 'description': 'bone ridge width will be measured using a Caliper', 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'SECONDARY', 'title': 'Primary Stability of the Implants as Measured by the Insertion Torque Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'OG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '45', 'spread': '25.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'day of implant surgery', 'description': 'Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms).', 'unitOfMeasure': 'Newton-centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants'}, {'type': 'SECONDARY', 'title': 'Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter Baseline(After Implant Placement)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'OG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.7', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '8.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline(after implant placement)', 'description': 'The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. 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When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'OG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'spread': '6.87', 'groupId': 'OG000'}, {'value': '69.8', 'spread': '7.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks after implant placement', 'description': 'The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. 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Noting that some participants had multiple implants, data for 6 implants in the standard drilling (SD) protocol arm were not collected, which includes data for 4 participants'}, {'type': 'SECONDARY', 'title': 'Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 6 Weeks After Implant Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'OG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '6.16', 'groupId': 'OG000'}, {'value': '70.8', 'spread': '9.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks after implant placement', 'description': 'The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. 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Noting that some participants had multiple implants, data for 6 implants in the standard drilling (SD) protocol arm were not collected, which includes data for 4 participants'}, {'type': 'SECONDARY', 'title': 'Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 12 Weeks After Implant Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'OG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.8', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '7.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks after implant placement', 'description': 'The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Data for 1 implant in the OsseoDensification (OD) protocol arm were not collected, including 1 participant for whom no implant data were collected. Data for 1 implant in the standard drilling (SD) protocol arm were not collected, including 1 participant for whom no implant data were collected.'}, {'type': 'SECONDARY', 'title': 'Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'OG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'timeFrame': '6 months post implantation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'OG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.24', 'spread': '31.8', 'groupId': 'OG000'}, {'value': '-21.3', 'spread': '20.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post implantation', 'description': 'The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Noting that some participants had multiple implants, data for 3 implants in the OsseoDensification (OD) protocol arm were not collected, which includes data for 2 participants. Noting that some participants had multiple implants, data for 3 implants in the standard drilling (SD) protocol arm were not collected, which includes data for 2 participants'}, {'type': 'SECONDARY', 'title': 'Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'units': 'Implants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'OG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.61', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '-15.1', 'spread': '21.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post implantation', 'description': 'The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Implants', 'denomUnitsSelected': 'Implants', 'populationDescription': 'Noting that some participants had multiple implants, data for 3 implants in the OsseoDensification (OD) protocol arm were not collected, which includes data for 2 participants. Noting that some participants had multiple implants, data for 3 implants in the standard drilling (SD) protocol arm were not collected, which includes data for 2 participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OsseoDensification (OD) Protocol', 'description': 'OsseoDensification (OD) protocol: Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.'}, {'id': 'FG001', 'title': 'Standard Drilling (SD) Protocol', 'description': 'standard drilling (SD) protocol (NobelReplace® Conical): osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '15'}, {'groupId': 'FG001', 'numUnits': '20', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '20', 'numSubjects': '15'}, {'groupId': 'FG001', 'numUnits': '20', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Implants', 'preAssignmentDetails': '15 participants were enrolled. Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '50.67', 'spread': '14.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-12', 'size': 309644, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-22T13:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each participant served as their own control. Each participant had at least 1 control implant and at least 1 test implant.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2022-03-08', 'resultsFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2022-03-08', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-21', 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bone Ridge Width at Crest', 'timeFrame': 'day of implant surgery', 'description': 'bone ridge width will be measured using a Caliper'}, {'measure': 'Change in Bone Ridge Width at 5mm Apical From Crest', 'timeFrame': 'day of implant surgery', 'description': 'bone ridge width will be measured using a Caliper'}, {'measure': 'Change in Bone Ridge Width at 10mm Apical From Crest', 'timeFrame': 'day of implant surgery', 'description': 'bone ridge width will be measured using a Caliper'}], 'secondaryOutcomes': [{'measure': 'Primary Stability of the Implants as Measured by the Insertion Torque Values', 'timeFrame': 'day of implant surgery', 'description': 'Insertion torque refers to the force used to insert an implant into bone, and it is reported in units of Newton-Centimeters (N-cms).'}, {'measure': 'Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter Baseline(After Implant Placement)', 'timeFrame': 'baseline(after implant placement)', 'description': 'The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.'}, {'measure': 'Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 3 Weeks After Implant Placement', 'timeFrame': '3 weeks after implant placement', 'description': 'The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.'}, {'measure': 'Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 6 Weeks After Implant Placement', 'timeFrame': '6 weeks after implant placement', 'description': 'The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.'}, {'measure': 'Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 12 Weeks After Implant Placement', 'timeFrame': '12 weeks after implant placement', 'description': 'The Implant Stability Quotient (ISQ) value is a measurement used to assess the stability of dental implants. It is obtained by resonance frequency analysis and ranges from 1 to 100, with higher values indicating greater stability.'}, {'measure': 'Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)', 'timeFrame': '6 months post implantation'}, {'measure': 'Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform', 'timeFrame': '6 months post implantation', 'description': 'The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness.'}, {'measure': 'Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform', 'timeFrame': '6 months post implantation', 'description': 'The buccal bone thickness (BBT) was measured using cone beam computed tomography (CBCT). The percentage change in BBT was calculated by comparing the post-implant measurements to baseline values, with positive percentages indicating an increase in thickness and negative percentages indicating a decrease in thickness.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['osseodensification', 'ridge expansion'], 'conditions': ['Dental Implants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who understand and agree to this study.\n* Adequate Oral hygiene\n* One or more edentulous spaces, which are 10 weeks or longer after extractions\n\nExclusion Criteria:\n\n* Pregnancy.\n* Smoking of more than 5 cigarettes/day.\n* History of alcoholism or drug abuse during the last 5 years.\n* Uncontrolled Hypertension or diabetes.\n* Patient with malignant tumor.\n* Patients on daily dose of steroids.\n* Patients with history of chemotherapy or radiation for the last 12 months.'}, 'identificationModule': {'nctId': 'NCT05283928', 'briefTitle': 'Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol', 'orgStudyIdInfo': {'id': 'HSC-DB-21-0597'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OsseoDensification (OD) protocol', 'interventionNames': ['Device: OsseoDensification (OD) protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard drilling (SD) protocol', 'interventionNames': ['Device: standard drilling (SD) protocol (NobelReplace® Conical)']}], 'interventions': [{'name': 'OsseoDensification (OD) protocol', 'type': 'DEVICE', 'description': 'Osseodensification is a drilling process by which bone is being compacted and auto-grafted in an outwardly expanding direction from the osteotomy. When the osseodensification drills are being rotated in a reversed, non-cutting direction a strong and dense layer of bone is formed along the walls and base of the osteotomy.', 'armGroupLabels': ['OsseoDensification (OD) protocol']}, {'name': 'standard drilling (SD) protocol (NobelReplace® Conical)', 'type': 'DEVICE', 'description': 'osteotomy preparation through bone excavation is necessary in implant site development for the placement of dental implants. The process involves a forward cutting process with removal of bone tissue creating appropriate size osteotomy for the dental implant.', 'armGroupLabels': ['standard drilling (SD) protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Popi Stylianou, DDS,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Popi Stylianou', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}