NCT07467369

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 9, 2026

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • secondary implant stability

    (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.

    up to 6 months

Secondary Outcomes (4)

  • change in pain scores

    up to 7 days

  • change in labial bone thickness

    baseline and 6 months

  • Marginal bone loss

    up to 6 months

  • change in bone density

    up to 6 months

Study Arms (2)

Study group

EXPERIMENTAL
Procedure: ridge expansion by piezotome

Control Group

ACTIVE COMPARATOR
Procedure: ridge expansion by magnetic mallet

Interventions

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.

Control Group

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 .

Study group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

January 19, 2025

Primary Completion

July 21, 2025

Study Completion

July 21, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations