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Published case study of a non-surgical workflow in an inflammatory environment

Non-Surgical Workflow

Disclaimer: Magdent MED is CE marked for enhancing osseointegration. The protocol described below refers to non-surgical peri-implant tissue maintenance and is based on published clinical and preclinical evidence. This indication is considered off-label. The clinician is responsible for complying with local regulations and ethical frameworks when applying this protocol in daily practice.

Research: “A novel nonsurgical therapy for peri-implantitis using focused pulsed electromagnetic field: A pilot randomized double-blind controlled clinical trial,” Yaniv Mayer, Juan Khoury, Jacob Horwitz, Ofir Ginesin, Luigi Canullo, Eran Gabay, Hadar Z. Giladi.; Bioelectromagnetics, Volume 44, Issues 7-8, in 2023, on pages 144-155.

A novel nonsurgical therapy for peri-implantitis using focused pulsed electromagnetic field: A pilot randomized double-blind controlled clinical trial

1. Case Selection & Pre-Treatment Considerations

Use the MED in non-surgical implant maintenance cases where biologic support of healing, inflammation modulation, and peri-implant tissue stabilization are desired, without indication for surgical intervention.

Appropriate cases:

  • Early to moderate peri-implant inflammation
  • Residual pockets following implant restoration
  • Sites with radiographic bone loss not exceeding approximately 5 mm
  • Implants with retrievable restorations
  • Patients enrolled in periodontal maintenance programs

The MED is intended as an adjunct to standard mechanical debridement and not as a replacement for established non-surgical care.

Contraindications

  • Cardiac pacemakers or active implantable electronic devices
  • Ongoing systemic antibiotic therapy or chronic NSAID use
  • Medications significantly affecting bone or soft tissue healing
  • Untreated generalized periodontal disease
  • Heavy smoking habit (more than 10 cigarettes per day)

2. Implant Status & Access

  • The implant must be restored or restorable with access to the implant chamber.
  • The MED cannot be placed if the implant is submerged or if soft tissue coverage prevents exposure of the device.
  • Ensure that the implant connection is compatible with the MED system prior to treatment.

3. Mechanical Debridement & Site Preparation

  1. Administer local anesthesia as required.
  2. Remove the suprastructure:
    • Screw-retained restorations: unscrew and remove
    • Cemented restorations: section carefully to allow atraumatic removal
  3. Perform thorough mechanical debridement of the implant surface using non-metallic instruments such as Teflon-coated curettes and rotary brushes.
  4. Avoid damage to the implant surface or alteration of the implant geometry.
  5. Irrigate thoroughly and ensure the implant chamber is free of debris prior to MED placement.

4. MED Activation (Outside the Mouth)

  1. Remove the MED vial from the sterile tray.
  2. Place the vial into the Magdent activation socket.
  3. Press the activation button:
    • Blue blinking for approximately 3 seconds indicates activation
    • Blue solid light confirms the MED is active and ready for placement
  4. Once activated, remove the MED from the vial and transfer directly to the clinical field.

5. MED Placement

  1. Ensure the implant chamber is dry and clean.
  2. Seat the MED using the supplied 1.25 mm hex driver, maintaining alignment with the implant long axis.
  3. Tighten by hand only until passive seating is achieved. Apply restorative torque of up to 10 Ncm. Do not exceed recommended torque values.
  4. Reposition soft tissue around the MED and suture as preferred. Confirm that there is no occlusal interference with the opposing dentition.

6. Immediate Post-Treatment Instructions

  • The MED remains active for approximately 30 days following activation.
  • The device can remain in place until re-evaluation or prosthetic reinstallation.
  • Avoid electric toothbrushes during the first 30 days.
  • Encourage gentle brushing around the MED using a soft manual toothbrush.
  • If a provisional prosthesis is used, ensure adequate relief around the MED.

7. Follow-Up Protocol

At 2 weeks

  • Inspect peri-implant soft tissue maturation
  • Verify that the MED remains fully seated

At 4 weeks (30 days)

  • Remove the MED.
  • Reassess clinical parameters including probing depth and bleeding on probing.
  • A 2nd MED may be recommended in moderate to severe inflammatory cases, or when clinical findings at 30 days indicate that extended support would be beneficial.

This is an optional step and should be determined according to the initial severity and the tissue response following the first MED.

If a 2nd MED is used, repeat the procedures described in Sections 4 and 5 accordingly.

At 8–12 weeks

  • Reassess peri-implant tissue stability
  • Perform radiographic comparison if indicated
  • Proceed with prosthetic restoration when clinical stability is achieved

A second MED may be placed after 30 days in moderate to severe inflammatory cases or when clinical findings suggest additional biologic support would be beneficial.

8. Biological Rationale

Pulsed electromagnetic field (PEMF) delivered by the MED supports healing by:

  • Modulating inflammatory cytokine activity toward a pro-healing profile.
  • Supporting osteoblast activity and bone remodeling.
  • Promoting angiogenesis and soft tissue maturation.
  • Influencing peri-implant biofilm behavior under experimental conditions.

These mechanisms justify MED use as a biologic adjunct in non-surgical implant maintenance rather than as a stand-alone disease therapy.

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