- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467369
Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (
Comparison Between Magnetic Mallet and Piezotome in Atrophic Anterior Maxillary Ridge Expansion With Simultaneous Bone Graft and Implant Placement (Randomized Clinical Trial)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alexandria, Egypt
- Alexandria Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Control Group
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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.
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Experimental: Study group
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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 .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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secondary implant stability
Time Frame: up to 6 months
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(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.
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up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change in pain scores
Time Frame: up to 7 days
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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 )
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up to 7 days
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change in labial bone thickness
Time Frame: baseline and 6 months
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it will be measured on CBCT
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baseline and 6 months
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Marginal bone loss
Time Frame: up to 6 months
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it will be measured on CBCT
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up to 6 months
|
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change in bone density
Time Frame: up to 6 months
|
it will be measured on CBCT
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up to 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0915-05/2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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