Computer-Guided Ridge Split and Expansion Using an Electromagnetic Mallet

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-27

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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Dental implants are a durable and long-term choice for tooth replacement to provide both functional and aesthetic benefits. However, successful implantation is critical, as it needs a sufficient amount of bone to maintain an ideal implant pathway and avoid vital structures. Vertical and horizontal ridge defects might occur after tooth extraction.

The pattern of alveolar ridge defect after extraction is classified according to the Cologne Classification into horizontal, vertical, combination, and sinus defects. mild (up to 4 mm), moderate (4-8 mm), and significant (over 8 mm) atrophy.

Successful implant placement is difficult to maintain with insufficient bone height and width. Many surgical techniques were introduced for the horizontally collapsed ridges, such as ridge augmentation, block graft, guided bone regeneration, and onlay graft. But these techniques need a long period of time for reconstruction, and an additional surgery is required for delayed implant placement.

Among these techniques, the ridge-splitting technique was performed for treating horizontally collapsed ridges by means of splitting the deficient ridge followed by ridge expansion to accommodate simultaneous implant placement.

The concept of the ridge-splitting technique is to make a self-space-making defect. The ridge-splitting technique was introduced by Tatum Jr. in 1986 and reintroduced in 1990 by Scipioni et al. In 1994, the technique was adapted by Summers, who utilized the viscoelastic properties of bone by applying pressure in-between buccal and lingual cortical bones using Summers osteotome to increase the width of the bone.

The ridge-splitting technique allowed the clinician to achieve desirable results within the shortest period and provide ridge expansion with simultaneous implant placement without the need for additional surgery and increase wound healing and satisfaction of the patient. Different instruments were used for splitting, such as chisels, discs, saws, osteomes, piezo surgery, and electromagnetic mallets.

The electromagnetic mallet consists of a handpiece that produces electromagnetic pulses with a rapid, non-impact motion that transmits to its tip, allowing high-intensity and precise movements with reduced trauma, minimal tissue damage, a greater safety margin, improved surgical outcomes, and faster recovery times. The precise movements make the repeatability of the procedure more applicable, which is very difficult to obtain with manual instruments.

Computer-guided surgery provides predictable and accurate treatment planning and implant positioning. It permits visualizing the jawbones and vital anatomical structures for preserving them during guided surgery. Artificial intelligence (AI) refers to the ability of machines to execute tasks that traditionally require human intelligence. Enhancing the high-quality dental treatment and precision of patient management, diagnosis, and treatment planning.

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.

Conditions

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Reconstruction of Horizontal Ridge Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Freehand spit

conventional ridge splitting with conventional simultaneous implant placement

Group Type EXPERIMENTAL

free-hand ridge splitting

Intervention Type PROCEDURE

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.

computer-guided split

computer-guided ridge splitting assisted by artificial intelligence with simultaneous computer-guided implant placement.

Group Type EXPERIMENTAL

AI/guided ridge splitting

Intervention Type PROCEDURE

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.

Interventions

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free-hand ridge splitting

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.

Intervention Type PROCEDURE

AI/guided ridge splitting

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.
2. Age ranges from 18 to 40 years of both sexes.
3. Absence of any complicating systemic condition that may contraindicate surgical procedures and implant placement.
4. Adequate oral hygiene.
5. Eligible participants should present good general health and agree to random assignment to any of the two parallel study groups.
6. Participants had a minimum 3-month post-extraction healing period and a horizontal defect in the maxillary esthetic zone with at least a bone width of 3 mm.

Exclusion Criteria

1. Vertical ridge defect.
2. Undercut on the labial/buccal side.
3. Thick cortical bone without cancellous bone inside.
4. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes