Optimizing Alveolar Ridge Expansion

NCT07066930 | Not Yet Recruiting DMC

• 1 other identifier: HMUD2425177
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implant

Keywords

Ridge expansion; Osseodensification; Magnetic mallet; Dental implants

Outcome Measures

Primary Outcomes (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.

  4 Months

• 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.

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

Study Arms (2)

Magneto-Dynamic Ridge Splitting

EXPERIMENTAL

Participants in this arm will undergo ridge expansion using the Magnetic Mallet system. The procedure involves magneto-dynamic impulses to laterally expand the alveolar ridge prior to dental implant placement.

Procedure: Magneto-Dynamic Ridge Expansion

Versah Osseodensification

ACTIVE COMPARATOR

Participants in this arm will undergo ridge expansion using Versah drills (Densah burs) in osseodensification mode prior to dental implant placement.

Procedure: Osseodensification with Versah Drills

Interventions

Magneto-Dynamic Ridge Expansion PROCEDURE

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.

Magneto-Dynamic Ridge Splitting

Osseodensification with Versah Drills PROCEDURE

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)

Versah Osseodensification

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Adequate oral hygiene and commitment to postoperative care and follow-up visits.
• Signed informed consent form.

You may not qualify if:

• 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).
• Pregnant or breastfeeding women.
• History of substance abuse or psychiatric disorders that could impair compliance with study protocol.

Sponsors & Collaborators

• Hawler Medical University: lead
• Universidad de Granada: collaborator

Study Sites (1)

Oral and Maxillofacial Surgery Department, College of Dentistry, Hawler Medical University, Erbil, Kurdistan Region, Iraq.

Erbil, 44001, Iraq

Location

Related Links

• Related Info
• Related Info

Study Officials

• Jodal Ahmed, PhD

  Oral and Maxillofacial Surgery Department, College of Dentistry, Hawler Medical University, Erbil, Kurdistan Region, Iraq.

  STUDY DIRECTOR

Central Study Contacts

Abduljaleel Azad Samad, PhD

CONTACT

+9647504843344; abduljaleel.azad@hmu.edu.krd

Pablo Galindo Moreno, PhD

CONTACT

0034636484000; pgalindo@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Optimizing Alveolar Ridge Expansion: A Clinical Comparison of Magneto-Dynamic Ridge Splitting and Versah Osseodensification Techniques

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

IR (1)