Optimizing Alveolar Ridge Expansion

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHawler Medical University

About this trial

The goal of this clinical trial is to compare two surgical techniques-Magneto-Dynamic Ridge Splitting and Versah Osseodensification-for expanding narrow alveolar ridges in adults requiring dental implant placement. The main questions it aims to answer are:

Which technique better preserves alveolar bone width after surgery?

Which method results in higher primary implant stability?

Researchers will compare ridge splitting using the Magnetic Mallet to ridge expansion using Versah drills to see if one technique leads to better clinical outcomes, such as improved bone preservation, greater implant stability, and favorable soft tissue response.

Participants will:

Undergo ridge expansion surgery using either the Magnetic Mallet or Versah drills, followed by immediate dental implant placement.

Receive CBCT scans before and 4 months after surgery to measure bone changes.

Undergo implant stability testing using the ISQ (Implant Stability Quotient) method.

Have intraoral scans to evaluate changes in soft tissue volume and thickness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 70 years.

Partially edentulous patients requiring ridge expansion prior to dental implant placement.

Alveolar ridge width between 4 mm and 6 mm as measured on CBCT.

Sufficient vertical bone height for implant placement without the need for vertical augmentation.

Disqualifiers

Presence of systemic conditions contraindicating oral surgery (e.g., uncontrolled diabetes, immune-compromised status).

History of bisphosphonate therapy or radiation therapy to the head and neck region.

Active periodontal disease or untreated oral infections.

Heavy smokers (more than 10 cigarettes per day).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magneto-Dynamic Ridge Expansion

    Procedure/Surgery

    A ridge expansion technique using the Magnetic Mallet device. Controlled magneto-dynamic impulses are applied to split the alveolar ridge and compact bone prior to immediate implant placement.

  • Osseodensification with Versah Drills

    Procedure/Surgery

    A ridge expansion method using Versah drills (Densah burs) in osseodensification mode. The drills densify bone without removing it, enhancing bone density and implant stability. Arm Assignment: Versah Osseodensification (Active Comparator arm)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Magneto-Dynamic Ridge SplittingExperimental treatment 1 intervention
Group B: Versah OsseodensificationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Alveolar Ridge Width (Buccolingual Dimension)

Measurement of alveolar ridge width in millimeters using Cone Beam Computed Tomography (CBCT) to assess the horizontal bone gain after ridge expansion with either the Magneto-Dynamic Ridge Splitting or Versah Osseodensification technique.

Time frame
4 Months
2

Change in Alveolar Ridge Width (Buccolingual Dimension)

Measurement of alveolar ridge width in millimeters using Cone Beam Computed Tomography (CBCT) to assess the horizontal bone gain after ridge expansion with either the Magneto-Dynamic Ridge Splitting or Versah Osseodensification technique.

Time frame
Baseline (pre-operative) and 4 months post-surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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Hawler Medical University

Lead sponsor

Universidad de Granada

Collaborator

This trial is not recruiting at the moment. You can still explore other options: