Alveolar Bone Loss, Dental Implant, Osseodensification Drilling Technique
Conditions
Keywords
Visual Analog Scale, CBCT, Maxillary bone, osseointegration
Brief summary
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
Detailed description
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
Interventions
implant site preparation using sequential rotary drills according to standard protocol.
DEVICEMagnetic mallet osteotomy
Implant site preparation using controlled electromagnetic impulses for bone condensation.
Sponsors
University of Mosul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
where: patients with 1. healed edentulous posterior maxilla 2. residual vertical bone height ≥ 11 mm, allowing implant placement without sinus augmentation 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| implant stability | immediately after implant placement and at 3 months postoperatively | Implant stability was assessed using Implant Stability Quotient (ISQ) values , ISQ \> 70: High stability. ISQ 60-69: Moderate stability. ISQ \< 60: Low stability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 7 days after surgery | 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). |
Countries
Iraq
Contacts
PRINCIPAL_INVESTIGATORAlyaa I. Naser, BDS, MSc. Ph.D., assist. Prof.
Department of OMFS, College of Dentistry, University of Mosul, Nineveh, Iraq
STUDY_CHAIRZaid Adel Alshamaa, Specialized Dentist BDS MSc
. International trainer in laser dentistry, former lecturer in college of dentistry
Outcome results
None listed