Impact of Pulsed Electromagnetic Field (PEMF) on Human Peri-implant Tissues

NCT06516523 | Completed DMC

• 1 other identifier: 52969221.0.0000.5193
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Pulsed Electromagnetic field (PEMF) has been shown to heighten bone regeneration and wound healing in various clinical areas, including dentistry. In Oral implantology, PEMF stimulation may enhance peri-implant bone formation and secondary stability and modulate the peri-implant microbiome. This randomized controlled study will evaluate:

1. 1.the impact of PEMF around interim additive manufacturing (AM) implants immediately loaded and retrieved from human jaws after 60 days.
2. 2.the effect of PEMF on diseased dental implants using non-surgical therapy.

Conditions

Periodontitis; Dental Plaque

Outcome Measures

Primary Outcomes (2)

• Non-surgical Treatment of peri-implantitis

  reduction of probing depth

  12 months

• Bone formations under PEMF

  BIC% increase

  2 months

Study Arms (4)

PEMF and Bone Formation

EXPERIMENTAL

Use of activated miniaturized device with PEMF

Procedure: PEMF and Control/Sham; Device: PEMF and without PEMF

Control SHAM PEMF

PLACEBO COMPARATOR

Use of SHAM miniaturized device with PEMF (without Pulse)

Procedure: PEMF and Control/Sham; Device: PEMF and without PEMF

Non-surgical treament of peri-implantitis with PEMF

ACTIVE COMPARATOR

USE of PEMF on the microbiome modulation and bone formation under inflammatory conditions

Procedure: PEMF and Control/Sham; Device: PEMF and without PEMF

Non-surgical treatment of peri-implantitis without PEMF

PLACEBO COMPARATOR

USE of SHAM (no PEMF) on the microbiome modulation and bone formation under inflammatory conditions

Procedure: PEMF and Control/Sham; Device: PEMF and without PEMF

Interventions

PEMF and Control/Sham PROCEDURE

Use o PEMF on test implants (treatment of peri-implantitis and bone formation) Use of PEMF on experimental implants (Bone-to-implant contact)

Also known as: Bone regeneration, Treatment of peri-implantitis

Control SHAM PEMF; Non-surgical treament of peri-implantitis with PEMF; Non-surgical treatment of peri-implantitis without PEMF; PEMF and Bone Formation

PEMF and without PEMF DEVICE

Use o PEMF on test implants (treatment of peri-implantitis and bone formation)

Also known as: Treatment of peri-implantitis

Control SHAM PEMF; Non-surgical treament of peri-implantitis with PEMF; Non-surgical treatment of peri-implantitis without PEMF; PEMF and Bone Formation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bone formation
• good systemic and oral health
• sufficient native bone to place implants of 3.0 mm diameter and 10 mm length for the bone formation arm
• treatment of peri-implantitis
• patients aged 18-85 years with evidence of peri-implant crestal bone loss greater than 3mm but not more than 5mm;
• the presence of bleeding on probing or suppuration;
• an implant pocket depth of 6-8 mm;
• implants with an internal hex connection of 3.75-4.1mm diameter;
• implant-supported restoration that could be removed and later refitted
• patients who adhered to their scheduled periodontal maintenance visits.

You may not qualify if:

• patients consuming medications that might affect soft and hard tissue healing/health (such as calcium channel blockers, immunosuppressive, and anticonvulsive medications)
• patients currently taking systemic antibiotics
• chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) on a long-term basis (excluding low dose aspirin);
• presence of a pacemaker; patients with periodontal disease;
• cigarette smoking of more than 10 cigarettes a day
• missing data in patient's files.

Sponsors & Collaborators

• University of Guarulhos: lead

Study Sites (1)

Guarulhos University

Guarulhos, São Paulo, 073040, Brazil

Location

Related Publications (1)

• Faveri M, Miquelleto DEC, Bueno-Silva B, Pingueiro JMS, Figueiredo LC, Dolkart O, Yakobson E, Barak S, Feres M, Shibli JA. Antimicrobial effects of a pulsed electromagnetic field: an in vitro polymicrobial periodontal subgingival biofilm model. Biofouling. 2020 Aug;36(7):862-869. doi: 10.1080/08927014.2020.1825694. Epub 2020 Sep 29.

  PMID: 32993357 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Dental Plaque

Interventions

Bone Regeneration

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Bone Remodeling; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Regeneration; Biological Phenomena

Study Officials

• Jamil Shibli

  Guaurlhos University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 24, 2024
• Study Start: February 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: July 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)