NCT07424820

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Nov 2025Jul 2026

Study Start

First participant enrolled

November 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 14, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

Visual Analog ScaleCBCTMaxillary boneosseointegration

Outcome Measures

Primary Outcomes (1)

  • implant stability

    Implant stability was assessed using Implant Stability Quotient (ISQ) values , ISQ \> 70: High stability. ISQ 60-69: Moderate stability. ISQ \< 60: Low stability.

    immediately after implant placement and at 3 months postoperatively

Secondary Outcomes (1)

  • postoperative pain

    7 days after surgery

Study Arms (2)

Conventional Drilling Group

ACTIVE COMPARATOR

participants in this arm will undergo implant site preparation using the conventional drilling osteotomy technique according to standard clinical protocols before dental implant placement.

Device: Conventional drilling osteotomy

Magnetic Mallet Group

EXPERIMENTAL

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.

Device: Magnetic mallet osteotomy

Interventions

implant site preparation using sequential rotary drills according to standard protocol.

Conventional Drilling Group

Implant site preparation using controlled electromagnetic impulses for bone condensation.

Magnetic Mallet Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mosul/ College of Dentistry

Mosul, Mosul, +964, Iraq

Location

Related Publications (17)

  • 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.

    RESULT
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.

  • 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.

  • 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.

  • Misch CE. Bone density: a key determinant for clinical success. In: Contemporary Implant Dentistry. 2nd ed. St. Louis: Mosby; 1999. p. 109-118.

    RESULT
  • 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.

  • 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.

  • 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.

    RESULT
  • 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

    RESULT
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Alyaa I. Naser, BDS, MSc. Ph.D., assist. Prof.

    Department of OMFS, College of Dentistry, University of Mosul, Nineveh, Iraq

    PRINCIPAL INVESTIGATOR
  • Zaid Adel Alshamaa, Specialized Dentist BDS MSc

    . International trainer in laser dentistry, former lecturer in college of dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr Alyaa Ismael Naser

Study Record Dates

First Submitted

February 14, 2026

First Posted

February 20, 2026

Study Start

November 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
start date After publication of the primary study results, end date 5 years after publication
Access Criteria
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
More information

Locations