Computer-Guided Ridge Split and Expansion Using an Electromagnetic Mallet

ConditionReconstruction of Horizontal Ridge Defects

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-40

SponsorKafrelsheikh University

About this trial

The current trial aims to assess the efficacy of utilizing the electromagnetic mallet either by AI-assisted digital workflow or by the conventional freehand approach for reconstruction of horizontal ridge defects utilizing the ridge-split and expansion technique.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.

Age ranges from 18 to 40 years of both sexes.

Absence of any complicating systemic condition that may contraindicate surgical procedures and implant placement.

Adequate oral hygiene.

Disqualifiers

Vertical ridge defect.

Undercut on the labial/buccal side.

Thick cortical bone without cancellous bone inside.

Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, allergy to the used medications, uncooperative individuals or those unable to attend the study follow-up appointments.

Trial design

Design model

Parallel

Treatments tested in this trial

free-hand ridge splitting
Procedure/Surgery
Midcrestal incision will be followed by reflection of a full-thickness flap. A midcrestal cut without vertical osteotomy will be done using electromagnetic mallet unit, and then the cut will be extended deep to the implant length. The ridge will be expanded progressively using bone wedges. Dental implant fixtures will be placed stably with 1 mm minimal thickness of buccal bone plate. Surgical site will be completely closed, and wound edges will be sutured in a tension-free way.
AI/guided ridge splitting
Procedure/Surgery
The patient specific guides will be placed and fixed by monocortical osteosynthesis screws at the pre-planned positions at the labial buccal mucosa. A midcrestal cut will be performed on the crest of the alveolar ridge guided by the guide slits. The cuts will be expanded progressively using bone wedges through the guide slits to gradually lateralize and expand the labial alveolar plate of bone, so the labial cortex will move through the intentionally created micro gap till it touches the fitting aspect of the patient-specific guide. Implant drills will be inserted through the guiding holes in the surgical guide, and the implant osteotomy sites will be prepared. Finally, implants will be inserted in the osteotomy sites using a torque wrench in a self-tapping fashion, engaging palatal and basal bone for primary stability.

Treatment groups

22 Participants

are divided into 2 treatment groups

Group A: Freehand spitExperimental treatment 1 intervention

Group B: computer-guided splitExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

alveolar ridge width

CBCT will have taken immediately after surgery and at 6 and 12 months postoperatively

Time frame

12 months

Secondary outcomes

vertical bone height

CBCT will be taken immediately after surgery and at 6 and 12 months postoperatively to evaluate vertical bone height.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov

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