Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:43 AM
Study NCT ID:
NCT07424820
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-27
First Post:
2026-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Mallet Vs Conventional Drilling in D4 Posterior Maxilla
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor is blinded to the implant site preparation technique used in each participant to minimize assessment bias. Due to the nature of the surgical interventions, masking of the surgeon and participants is not feasible.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel-group clinical trial in which participants are randomly assigned to one of two intervention arms: implant site preparation using either conventional drilling osteotomy or magnetic mallet osteotomy. Each participant receives only one intervention, and outcomes are compared between the two groups.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-14', 'studyFirstSubmitQcDate': '2026-02-14', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant stability', 'timeFrame': 'immediately after implant placement and at 3 months postoperatively', 'description': 'Implant stability was assessed using Implant Stability Quotient (ISQ) values , ISQ \\> 70: High stability. ISQ 60-69: Moderate stability. ISQ \\< 60: Low stability.'}], 'secondaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': '7 days after surgery', 'description': 'Postoperative pain was assessed using a 10-point Visual Analog Scale (VAS), Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Visual Analog Scale', 'CBCT', 'Maxillary bone', 'osseointegration'], 'conditions': ['Alveolar Bone Loss', 'Dental Implant', 'Osseodensification Drilling Technique']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Agha RA, Mathew G, Rashid R, Kerwan A, Al-Jabir A, Sohrabi C, Franchi T, Nicola M, Agha M. Transparency in the reporting of artificial intelligence-the TITAN guideline. Premier Journal of Science. 2025;10:100082.'}, {'pmid': '25876078', 'type': 'RESULT', 'citation': 'Cappare P, Vinci R, Di Stefano DA, Traini T, Pantaleo G, Gherlone EF, Gastaldi G. Correlation between Initial BIC and the Insertion Torque/Depth Integral Recorded with an Instantaneous Torque-Measuring Implant Motor: An in vivo Study. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e613-20. doi: 10.1111/cid.12294. Epub 2015 Apr 15.'}, {'pmid': '22897742', 'type': 'RESULT', 'citation': 'Crespi R, Cappare P, Gherlone E. A comparison of manual and electrical mallet in maxillary bone condensing for immediately loaded implants: a randomized study. Clin Implant Dent Relat Res. 2014 Jun;16(3):374-82. doi: 10.1111/j.1708-8208.2012.00485.x. Epub 2012 Aug 15.'}, {'pmid': '33019711', 'type': 'RESULT', 'citation': 'Menchini-Fabris GB, Toti P, Crespi G, Covani U, Crespi R. Distal Displacement of Maxillary Sinus Anterior Wall Versus Conventional Sinus Lift with Lateral Access: A 3-Year Retrospective Computerized Tomography Study. Int J Environ Res Public Health. 2020 Oct 1;17(19):7199. doi: 10.3390/ijerph17197199.'}, {'pmid': '23748321', 'type': 'RESULT', 'citation': 'Crespi R, Cappare P, Gherlone EF. Electrical mallet in implants placed in fresh extraction sockets with simultaneous osteotome sinus floor elevation. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):869-74. doi: 10.11607/jomi.2679.'}, {'pmid': '35055423', 'type': 'RESULT', 'citation': 'Bennardo F, Barone S, Vocaturo C, Nucci L, Antonelli A, Giudice A. Usefulness of Magnetic Mallet in Oral Surgery and Implantology: A Systematic Review. J Pers Med. 2022 Jan 14;12(1):108. doi: 10.3390/jpm12010108.'}, {'pmid': '8055503', 'type': 'RESULT', 'citation': 'Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.'}, {'pmid': '32475099', 'type': 'RESULT', 'citation': "Giudice A, Bennardo F, Antonelli A, Barone S, Wagner F, Fortunato L, Traxler H. Influence of clinician's skill on primary implant stability with conventional and piezoelectric preparation techniques: an ex-vivo study. J Biol Regul Homeost Agents. 2020 Mar-Apr;34(2):739-745. doi: 10.23812/20-96-L-53. No abstract available."}, {'pmid': '24381734', 'type': 'RESULT', '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.'}, {'type': 'RESULT', 'citation': 'Misch CE. Bone density: a key determinant for clinical success. In: Contemporary Implant Dentistry. 2nd ed. St. Louis: Mosby; 1999. p. 109-118.'}, {'pmid': '39463674', 'type': 'RESULT', 'citation': 'Sheikh Ibrahim A, Jaafo MH. A Comparison of Different Implant Site Preparation Techniques in Low-Density Bone: An Ex-Vivo Study. Cureus. 2024 Sep 27;16(9):e70318. doi: 10.7759/cureus.70318. eCollection 2024 Sep.'}, {'pmid': '32509230', 'type': 'RESULT', 'citation': 'Hindi AR, Bede SY. The effect of osseodensification on implant stability and bone density: A prospective observational study. J Clin Exp Dent. 2020 May 1;12(5):e474-e478. doi: 10.4317/jced.56727. eCollection 2020 May.'}, {'type': 'RESULT', 'citation': '5. Lekholm U, Zarb GA. Patient selection and preparation. In: Brånemark PI, Zarb GA, Albrektsson T, editors. Osseointegration in Clinical Dentistry. Chicago: Quintessence Publishing Co; 1985. p. 199-209.'}, {'type': 'RESULT', 'citation': 'Negidah TB, shehab aF, Hatem H, Fanous SZ, azab m. Implant Site Preparation Using Conventional Drilling Technique Versus Magnetic Malleting Technique (Randomized Clinical Study).. Future Dental Journal. 2024; 9(2):87-92. doi: https://doi.org/10.54623/fdj.9023. This'}, {'pmid': '15533124', 'type': 'RESULT', 'citation': 'Pjetursson BE, Tan K, Lang NP, Bragger U, Egger M, Zwahlen M. A systematic review of the survival and complication rates of fixed partial dentures (FPDs) after an observation period of at least 5 years. Clin Oral Implants Res. 2004 Dec;15(6):625-42. doi: 10.1111/j.1600-0501.2004.01117.x.'}, {'pmid': '35060200', 'type': 'RESULT', 'citation': 'Walter P, Pirc M, Ioannidis A, Husler J, Jung RE, Hammerle CHF, Thoma DS. Randomized controlled clinical study comparing two types of two-piece dental implants supporting fixed restorations-Results at 8 years of loading. Clin Oral Implants Res. 2022 Mar;33(3):333-341. doi: 10.1111/clr.13893. Epub 2022 Feb 3.'}, {'pmid': '6809663', 'type': 'RESULT', 'citation': 'Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether the magnetic mallet technique improves primary implant stability and clinical outcomes compared with conventional drilling during dental implant placement in the posterior maxilla with soft bone quality.\n\nThe main questions it aims to answer are:\n\nDoes the magnetic mallet technique result in higher primary implant stability compared with conventional drilling?\n\nDoes the magnetic mallet technique reduce surgical trauma and related complications compared with conventional drilling?\n\nResearchers will compare the magnetic mallet technique with conventional drilling to determine differences in implant stability, bone response, and clinical outcomes.\n\nParticipants will:\n\nUndergo dental implant placement using either the magnetic mallet technique or conventional drilling.\n\nBe clinically and radiographically evaluated for implant stability and postoperative outcomes during follow-up', 'detailedDescription': 'This study is a prospective clinical trial designed to compare the magnetic mallet technique with conventional drilling for dental implant placement in the posterior maxilla characterized by soft bone quality (D4 bone). Achieving adequate primary implant stability in this region remains a clinical challenge, and techniques that preserve and condense bone may improve treatment outcomes.\n\nThe magnetic mallet technique uses controlled electromagnetic impulses to prepare the implant site through bone condensation rather than bone removal, potentially enhancing primary stability and reducing surgical trauma. In contrast, conventional drilling relies on rotational cutting instruments that remove bone and may generate heat, which can negatively affect bone vitality.\n\nEligible participants requiring dental implants in the posterior maxillary region will be randomly allocated to one of two groups: implant site preparation using the magnetic mallet technique or conventional drilling. All implants will be placed following standardized surgical protocols.\n\nPrimary outcomes will include the assessment of primary implant stability using objective measurement methods. Secondary outcomes will evaluate peri-implant bone response, intraoperative and postoperative complications, and overall clinical performance during follow-up.\n\nThe results of this study aim to provide clinical evidence regarding the effectiveness and safety of the magnetic mallet technique compared with conventional drilling, particularly in soft posterior maxillary bone, to support evidence-based decision-making in implant dentistry'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria where: patients with\n\n1. healed edentulous posterior maxilla\n2. residual vertical bone height ≥ 11 mm, allowing implant placement without sinus augmentation\n3. bone quality classified as Type IV (D4) according to the Lekholm and Zarb classification\n\nExclusion Criteria where: patients with Systemic diseases affecting bone healing, active oral infection, smoking habits, or a need for bone augmentation procedures were excluded.'}, 'identificationModule': {'nctId': 'NCT07424820', 'briefTitle': 'Magnetic Mallet Vs Conventional Drilling in D4 Posterior Maxilla', 'organization': {'class': 'OTHER', 'fullName': 'University of Mosul'}, 'officialTitle': 'Clinical Comparative Analysis of Magnetic Mallet and Conventional Drilling Techniques for Implant Placement in D4 Bone: A Prospective Study', 'orgStudyIdInfo': {'id': 'UoM. dent. 26/1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Drilling Group', 'description': 'participants in this arm will undergo implant site preparation using the conventional drilling osteotomy technique according to standard clinical protocols before dental implant placement.', 'interventionNames': ['Device: Conventional drilling osteotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Magnetic Mallet Group', 'description': 'participants in this arm will undergo implant site preparation using the magnetic mallet osteotomy technique, which prepares the implant site through controlled bone condensation prior to dental implant placement.', 'interventionNames': ['Device: Magnetic mallet osteotomy']}], 'interventions': [{'name': 'Conventional drilling osteotomy', 'type': 'DEVICE', 'description': 'implant site preparation using sequential rotary drills according to standard protocol.', 'armGroupLabels': ['Conventional Drilling Group']}, {'name': 'Magnetic mallet osteotomy', 'type': 'DEVICE', 'description': 'Implant site preparation using controlled electromagnetic impulses for bone condensation.', 'armGroupLabels': ['Magnetic Mallet Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+964', 'city': 'Mosul', 'state': 'Mosul', 'country': 'Iraq', 'facility': 'University of Mosul/ College of Dentistry', 'geoPoint': {'lat': 36.335, 'lon': 43.11889}}], 'overallOfficials': [{'name': 'Alyaa I. Naser, BDS, MSc. Ph.D., assist. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of OMFS, College of Dentistry, University of Mosul, Nineveh, Iraq'}, {'name': 'Zaid Adel Alshamaa, Specialized Dentist BDS MSc', 'role': 'STUDY_CHAIR', 'affiliation': '. International trainer in laser dentistry, former lecturer in college of dentistry'}]}, 'ipdSharingStatementModule': {'url': 'https://clinicaltrials.gov/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'start date After publication of the primary study results, end date 5 years after publication', 'ipdSharing': 'YES', 'description': 'individual participant data (IPD) that underlie the results reported in this study, after de-identification, will be shared with other researchers upon reasonable request. The data will be available beginning after publication of the primary results and may be used for academic and research purposes only. Requests should be directed to the corresponding author, and access will be granted following approval and completion of a data use agreement.', 'accessCriteria': 'de-identified individual participant data and supporting documents, including the study protocol and statistical analysis plan, will be available to qualified researchers for academic and research purposes only. Access will be granted upon reasonable request to the corresponding author, following review and approval of the request and completion of a data use agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Mosul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Dr Alyaa Ismael Naser', 'investigatorFullName': 'Alyaa Ismael Naser', 'investigatorAffiliation': 'University of Mosul'}}}}