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Completed

NCT Number: NCT07467369

Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (

Background: teeth loss in the anterior maxilla initiate residual ridge resorption, especially in the anterior region. The consequence of this resorption is a gradual medial or palatal shift of the crest of maxilla. This results in change in facial morphology as result of diminished maxillary lip support. This may also lead to compromised occlusal relationship of prosthetic teeth as they are positioned labially to the crest of alveolar ridge.

Aim: to compare the use of magnetic mallet and piezotome in atrophic anterior maxillary ridge expansion with simultaneous bone graft and implant placement.Materials and Methods: 20 patients with anterior atrophic maxilla will be included in the study. Patients will be divided into two groups, group A the bone expansion will be done by the magnetic mallet. Group B the bone expansion will be done by the piezotome , both groups will have bone graft and implant.

clinical evaluation will include intra operative and post operative evaluation, primary and secondary stability, operative time and time . Radiographic evaluation will include bone density and marginal bone loss around the tnalpmi

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • alveolar ridge width from 3-5 mm
  • Patient with missing more than two anterior maxillary teeth
  • Patient with good oral hygiene and acceptable inter-arch space[8-12mm] for the restoration
  • D3 bone density

Exclusion criteria

  • Heavy smoker, alcohol abuse, parafunctional habits.
  • Patient with uncontrolled hypertension, uncontrolled diabetes, on radiation therapy

Treatment and study plan

ridge expansion by magnetic mallet

Procedure

Surgery will be performed under local anesthesia using articaine with 1:100,000 adrenaline, a full-thickness buccal and palatal flaps will be raised. After the flaps were reflected, the crestal incision will be performed into the bone to perform an intra-osseous groove with an n. 64 beaver blade attached to magnetic mallet, this groove will be continued apically down to 7-11mm. The implant site will be created by expanding the bone tissue both laterally against the preexisting walls and apically by using osteotome attached to magnetic mallet, in this way the buccal plate will be slowly dislocated in a facial direction.

ridge expansion by piezotome

Procedure

Surgery will be performed under local anesthesia using articaine with 1:100,000 adrenaline, after exposing the ridge, a sagittal osteotomy of 1mm depth will be outlined in the cortical bone by using sharp piezoelectric insert no. OT2. After that the sagittal osteotomic cut will be deepened with a 0.25 mm diameter piezoelectric micro-saw no. OT12s toward apical direction, at depth equivalent to the planned implant length. When the bone cuts will be completed, the ridges will be separated in buccal/lingual direction using densah burs . Then implants will be placed within the confines of the newly created space .

Primary outcomes

  1. secondary implant stability

    Time frame: up to 6 months

    (2ry stability ) will be recorded after 6 months by using osstell device. The result is presented in form of ISQ value from 1to 100, the higher the ISQ the higher the stability of implant.

Secondary outcomes

  1. change in pain scores

    Time frame: up to 7 days

    Pain will be assessed for 7 days postoperatively using 10-point visual analouge scale (VAS)(0-1=None, 2-4=mild, 5-7=moderate, 8-10=severe )

  2. change in labial bone thickness

    Time frame: baseline and 6 months

    it will be measured on CBCT

  3. Marginal bone loss

    Time frame: up to 6 months

    it will be measured on CBCT

  4. change in bone density

    Time frame: up to 6 months

    it will be measured on CBCT

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Comparison Between Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (Randomized Clinical Trial)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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