Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:28 PM
Study NCT ID:
NCT06034067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-24
First Post:
2023-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osseodensification Versus Conventional Drilling for Implant Site Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '\\- Double-blinded as both the participants and outcome accessors of radiographic outcomes will be blinded to the intervention.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Prospective, in which participants will be recruited and then followed up throughout a specified period of time.\n* Randomized, parallel designed, concurrent controlled trial with participants randomly allocated to either control or test groups.\n* Double-blinded as both the participants and outcome accessors of radiographic outcomes will be blinded to the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2023-08-27', 'studyFirstSubmitQcDate': '2023-09-10', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Implant stability quotient (ISQ values) using resonance frequency analysis', 'timeFrame': 'Upto 36 months', 'description': 'Resonance frequency analysis (RFA) will be used to determine stability (the level of osseointegration) in dental implants. The stability will be presented as an implant stability quotient (ISQ) value. The measurements will be recorded at time of implant placement, delivery of implant restoration (baseline), one year of implant restoration and annually up to three years using resonance frequency analysis.'}, {'measure': 'Implant failure rate', 'timeFrame': 'Upto 36 months', 'description': 'Implant failure rate will be assessed clinically after one year of implant restoration and annually up to three years.'}], 'secondaryOutcomes': [{'measure': 'Changes in peri-implant marginal bone level (in mm)', 'timeFrame': 'Upto 36 months', 'description': 'Changes in peri-implant marginal bone level will be assessed at implant placement, delivery of implant restoration (baseline), one year of implant restoration and annually up to three years using standardized peri-apical radiograph. The changes in peri-implant marginal bone levels will be recorded in millimeters'}, {'measure': 'Descriptive evaluation of biological and technical complications associated with dental implant restorations', 'timeFrame': 'Upto 36 months', 'description': 'Descriptive evaluation of biological and technical complications will be recorded during the follow-up period'}, {'measure': 'Patient postoperative experience ( visual analogue scale )', 'timeFrame': 'Upto 10 days', 'description': "Patient postoperative experience will be assessed using visual analogue scale during the first week following implant placement; the scale consists of a 10cm line, with end points representing 0 ('no pain') and 10 ('unbearable/worst pain'). The participant will be asked to place a mark on he line indicating the level of pain that he/she experienced."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osseointegration', 'bone density', 'osteotomy', 'primary stability'], 'conditions': ['Dental Implant Failed', 'Jaw, Edentulous, Partially', 'Edentulous Alveolar Ridge', 'Osseointegration Failure of Dental Implant']}, 'referencesModule': {'references': [{'pmid': '8329101', 'type': 'BACKGROUND', 'citation': 'Albrektsson T, Zarb GA. Current interpretations of the osseointegrated response: clinical significance. Int J Prosthodont. 1993 Mar-Apr;6(2):95-105.'}, {'pmid': '23237585', 'type': 'BACKGROUND', 'citation': 'Atieh MA, Alsabeeha NH, Faggion CM Jr, Duncan WJ. The frequency of peri-implant diseases: a systematic review and meta-analysis. J Periodontol. 2013 Nov;84(11):1586-98. doi: 10.1902/jop.2012.120592. Epub 2012 Dec 13.'}, {'pmid': '17974108', 'type': 'BACKGROUND', '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': '19228101', 'type': 'BACKGROUND', 'citation': 'Buser D, Halbritter S, Hart C, Bornstein MM, Grutter L, Chappuis V, Belser UC. Early implant placement with simultaneous guided bone regeneration following single-tooth extraction in the esthetic zone: 12-month results of a prospective study with 20 consecutive patients. J Periodontol. 2009 Jan;80(1):152-62. doi: 10.1902/jop.2009.080360.'}, {'pmid': '11168257', 'type': 'BACKGROUND', 'citation': 'Buser D, von Arx T, ten Bruggenkate C, Weingart D. Basic surgical principles with ITI implants. Clin Oral Implants Res. 2000;11 Suppl 1:59-68. doi: 10.1034/j.1600-0501.2000.011s1059.x.'}, {'pmid': '29930793', 'type': 'BACKGROUND', 'citation': 'Di Stefano DA, Perrotti V, Greco GB, Cappucci C, Arosio P, Piattelli A, Iezzi G. The effect of undersizing and tapping on bone to implant contact and implant primary stability: A histomorphometric study on bovine ribs. J Adv Prosthodont. 2018 Jun;10(3):227-235. doi: 10.4047/jap.2018.10.3.227. Epub 2018 Jun 12.'}, {'pmid': '19897823', 'type': 'BACKGROUND', 'citation': 'Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.'}, {'pmid': '27741329', 'type': 'BACKGROUND', 'citation': 'Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.'}, {'pmid': '33671038', 'type': 'BACKGROUND', 'citation': 'Inchingolo AD, Inchingolo AM, Bordea IR, Xhajanka E, Romeo DM, Romeo M, Zappone CMF, Malcangi G, Scarano A, Lorusso F, Isacco CG, Marinelli G, Contaldo M, Ballini A, Inchingolo F, Dipalma G. The Effectiveness of Osseodensification Drilling Protocol for Implant Site Osteotomy: A Systematic Review of the Literature and Meta-Analysis. Materials (Basel). 2021 Feb 28;14(5):1147. doi: 10.3390/ma14051147.'}, {'pmid': '24381734', 'type': 'BACKGROUND', 'citation': 'Javed F, Ahmed HB, Crespi R, Romanos GE. Role of primary stability for successful osseointegration of dental implants: Factors of influence and evaluation. Interv Med Appl Sci. 2013 Dec;5(4):162-7. doi: 10.1556/IMAS.5.2013.4.3. Epub 2013 Dec 20.'}, {'pmid': '16672018', 'type': 'BACKGROUND', 'citation': 'Lioubavina-Hack N, Lang NP, Karring T. Significance of primary stability for osseointegration of dental implants. Clin Oral Implants Res. 2006 Jun;17(3):244-50. doi: 10.1111/j.1600-0501.2005.01201.x.'}, {'pmid': '9922740', 'type': 'BACKGROUND', 'citation': 'Meredith N. Assessment of implant stability as a prognostic determinant. Int J Prosthodont. 1998 Sep-Oct;11(5):491-501.'}, {'pmid': '9693511', 'type': 'BACKGROUND', 'citation': 'Sennerby L, Meredith N. Resonance frequency analysis: measuring implant stability and osseointegration. Compend Contin Educ Dent. 1998 May;19(5):493-8, 500, 502; quiz 504.'}, {'pmid': '18412573', 'type': 'BACKGROUND', 'citation': 'Sennerby L, Meredith N. Implant stability measurements using resonance frequency analysis: biological and biomechanical aspects and clinical implications. Periodontol 2000. 2008;47:51-66. doi: 10.1111/j.1600-0757.2008.00267.x. No abstract available.'}, {'pmid': '26584202', 'type': 'BACKGROUND', 'citation': 'Trisi P, Berardini M, Falco A, Podaliri Vulpiani M. New Osseodensification Implant Site Preparation Method to Increase Bone Density in Low-Density Bone: In Vivo Evaluation in Sheep. Implant Dent. 2016 Feb;25(1):24-31. doi: 10.1097/ID.0000000000000358.'}, {'pmid': '19522976', 'type': 'BACKGROUND', 'citation': 'Trisi P, Perfetti G, Baldoni E, Berardi D, Colagiovanni M, Scogna G. Implant micromotion is related to peak insertion torque and bone density. Clin Oral Implants Res. 2009 May;20(5):467-71. doi: 10.1111/j.1600-0501.2008.01679.x.'}]}, 'descriptionModule': {'briefSummary': 'A total of 34 participants, who require replacement of an anterior or posterior single tooth with dental implant, will be randomly allocated to two equal sized groups. In the control group, the osteotomy site preparation will be prepared by using conventional surgical drills, while the test group site preparation will involve the use of Densah™ Burs (Versah Co., LLC., USA) as per the osseodensification protocol. In addition to evaluating implant stability, the trial will also report on implant and patient outcomes at various time points.', 'detailedDescription': 'Osseodensification technique has demonstrated increased primary stability and increased bone mineral density around the osteotomy site. The implants placed into osseous densification osteotomies have shown significant increase in insertion and removal torque values. This technique also burnishes bone along the inner layer of the osteotomy site and create a condensed layer of autografted bone along the periphery and apex of the implant. This would, in turn, increase the bone-implant contact enhancing the insertion torque values, and thus, primary implant stability. This new technique has not only shown increased primary implant stability when compared with conventional drilling, but also, shown to have similar clinical safety to conventional methods of osteotomy site preparation. Although osseodensification has been reported to enhance the clinical outcomes of implants by increasing primary stability, its long-term effects on implant stability measurements and implant survival rates are still not clear. The purpose of the present randomized controlled trial is to evaluate the stability of implants placed in sites prepared with either conventional drilling or osseodensification and report on implant and patient outcomes at various time points.\n\nObjectives:\n\nThe aims of the randomized controlled trial are:\n\n* To evaluate implant stability as measured by implant stability quotient (ISQ).\n* To evaluate the clinical, radiographic outcomes and implant survival rates.\n* To evaluate the need for additional bone augmentation at the time of implant placement.\n* To evaluate changes in peri-implant marginal bone level.\n* To evaluate bone quality as estimated by clinicians during osteotomy preparation.\n* To evaluate biological and technical complications during the follow-up period.\n* To evaluate patient reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 or over.\n* Require replacement of an anterior or posterior single tooth with dental implant.\n* Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).\n* Good compliance and commitment to attend follow-up review appointments.\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* Localized / generalized periodontitis.\n* Bone metabolic disease and/or taking medications that affect bone metabolism.\n* Long term use of non-steroidal anti-inflammatory medications.\n* History of malignancy, radiotherapy or chemotherapy.\n* Pregnant or lactating women.\n* Severe bruxism or parafunctional habits.\n* Participants, who have controlled medical condition or smokers, will not be excluded in this study'}, 'identificationModule': {'nctId': 'NCT06034067', 'briefTitle': 'Osseodensification Versus Conventional Drilling for Implant Site Preparation', 'organization': {'class': 'OTHER', 'fullName': 'Mohammed Bin Rashid University of Medicine and Health Sciences'}, 'officialTitle': 'Osseodensification Versus Conventional Drilling for Implant Site Preparation: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MBRU IRB-2021-61'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Osseodensification (test) group', 'description': "Implant site preparation will be completed using osseodensification technique where tapered multifluted burs (Densah Burs; Versah, MI, USA) will be used as per manufacturer's instructions.", 'interventionNames': ['Procedure: Osseodensification osteotomy preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard (control) group', 'description': "Implant site preparation will be completed using conventional drilling protocol technique where standardized drills provided by Straumann (Straumann®, Institute Straumann AG, Basel, Switzerland)) will be used as per manufacturer's instructions.", 'interventionNames': ['Procedure: Standardized osteotomy preparation']}], 'interventions': [{'name': 'Osseodensification osteotomy preparation', 'type': 'PROCEDURE', 'otherNames': ['Densah® burs, Versah co., USA'], 'description': 'The implant site will be prepared by raising a mucoperiosteal flap. Implant osteotomy will be prepared by using osseodensification technique using Versah burs and a dental implant will be placed. The flaps will then be replaced and sutured with 4/0 polyglycolic acid interrupted and mattress sutures.', 'armGroupLabels': ['Osseodensification (test) group']}, {'name': 'Standardized osteotomy preparation', 'type': 'PROCEDURE', 'otherNames': ['Straumann® Twist Drills, Straumann, Switzerland'], 'description': 'The implant site will be prepared by raising a mucoperiosteal flap. Implant osteotomy will be prepared by using either conventional surgical drills provided by Straumann implant systems and a dental implant will be placed. The flaps will then be replaced and sutured with 4/0 polyglycolic acid interrupted and mattress sutures.', 'armGroupLabels': ['Standard (control) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '505055', 'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Dubai Dental Hospital', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}], 'overallOfficials': [{'name': 'Maanas S Shah, BDS MSD CAGS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mohammed Bin Rashid University of Medicine and Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohammed Bin Rashid University of Medicine and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Maanas Shah', 'investigatorAffiliation': 'Mohammed Bin Rashid University of Medicine and Health Sciences'}}}}