Magnetic Mallet Vs Conventional Drilling in D4 Posterior Maxilla

Официальное название

Clinical Comparative Analysis of Magnetic Mallet and Conventional Drilling Techniques for Implant Placement in D4 Bone: A Prospective Study

Обзор

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. The main questions it aims to answer are: Does the magnetic mallet technique result in higher primary implant stability compared with conventional drilling? Does the magnetic mallet technique reduce surgical trauma and related complications compared with conventional drilling? Researchers will compare the magnetic mallet technique with conventional drilling to determine differences in implant stability, bone response, and clinical outcomes. Participants will: Undergo dental implant placement using either the magnetic mallet technique or conventional drilling. Be clinically and radiographically evaluated for implant stability and postoperative outcomes during follow-up

Подробное описание

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.

The 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.

Eligible 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.

Primary 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.

The 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

Вмешательства

• Устройство Conventional drilling osteotomy
  implant site preparation using sequential rotary drills according to standard protocol.
• Устройство Magnetic mallet osteotomy
  Implant site preparation using controlled electromagnetic impulses for bone condensation.

Первичные конечные точки

• implant stability [Срок оценки: immediately after implant placement and at 3 months postoperatively]

Вторичные конечные точки (1)

• postoperative pain [Срок оценки: 7 days after surgery]

Критерии участия

Inclusion Criteria where: patients with

• healed edentulous posterior maxilla
• residual vertical bone height ≥ 11 mm, allowing implant placement without sinus augmentation
• bone quality classified as Type IV (D4) according to the Lekholm and Zarb classification

Exclusion Criteria where: patients with Systemic diseases affecting bone healing, active oral infection, smoking habits, or a need for bone augmentation procedures were excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Ирак · 1 центр

• University of Mosul/ College of Dentistry — Mosul

Публикации

• 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.
• 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 25876078
• 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 22897742
• 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 33019711
• 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 23748321
• 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 35055423
• 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 8055503
• 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 32475099

Идентификаторы

NCT: NCT07424820 · UoM. dent. 26/1001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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