Microbiome Modulation by PEMF on Plaque Induced Mucositis in Human Jaws

NCT07045636 | Completed DMC

• 1 other identifier: PEMF and mucositis
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the impact of Pulsed Electromagnetic Field (PEMF) on mucositis induced in humans around dental implants and correlate these possible effects with the proteomic profile of implants with and without PEMF and teeth. The hypothesis is that PEMF may modulate bacterial biofilm formation around dental implants and enhance the host response following plaque-induced peri-implant mucositis. Secondary analysis will be the increase in the soft tissue volume using Intra-oral scanning (IOS).

Conditions

Microbial Colonization; Peri-Implantitis

Keywords

dental implants; peri-implantitis; mucositis; microbiome; proteomic

Outcome Measures

Primary Outcomes (1)

• Number of clusters of microorganism

  amount of genera and microbial species detected and/or altered (reduction and increase)

  time points 0, 3, 6, 7, 14, 21, 28, 42, and 60 days

Secondary Outcomes (1)

• Increase on the soft tissue volume using IOS

  time points 0, 3, 6, 7, 14, 21, 28, 42, and 60 days

Study Arms (2)

PEMF x Control (without PEMF)

EXPERIMENTAL

Test group - Activated MED (with PEMF) installed on the test implants during the 21 days Control group - Non-activated MED (without PEMF) installed and NOT activated on the control implants during 21 days

Other: PEMF abd Sham (control); Diagnostic Test: Teeth wih gingivits

Dental implants x teeth

NO INTERVENTION

Comparison between tooth and implants (with and without PEMF)

Interventions

Teeth wih gingivits DIAGNOSTIC_TEST

Comparison with dental implants

PEMF x Control (without PEMF)

PEMF abd Sham (control) OTHER

Dental implants receive MED that could (test) or could not (control/SHAM) be activated to emit PEMF

PEMF x Control (without PEMF)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• have at least 2 contiguous edentulous spaces
• more than 15 teeth
• have not undergone periodontal treatment for at least 6 months before the start of the study

You may not qualify if:

• with periodontal disease stages II to IV
• with peri-implantitis and/or mucositis (Shibli et al. 2015);
• individuals requiring previous grafting for implant insertion;
• diabetics;
• smokers or former smokers;
• pregnant women; lactating women;
• use of antibiotics or oral antiseptics in the last 6 months .

Sponsors & Collaborators

• Harvard School of Dental Medicine: collaborator
• Hospital Israelita Albert Einstein: collaborator
• Jamil awad shibli: lead

Study Sites (1)

Guarulhos University

Guarulhos, São Paulo, 073040, Brazil

Location

Related Publications (5)

• Souza JGS, Azevedo F, Borges MHR, Costa RC, Shiba T, Barak S, Mayer Y, Figueiredo LC, Feres M, Barao VAR, Shibli JA. Microbiome modulation of implant-related infection by a novel miniaturized pulsed electromagnetic field device. NPJ Biofilms Microbiomes. 2025 Feb 26;11(1):36. doi: 10.1038/s41522-025-00667-0.

  PMID: 40011461 BACKGROUND

• Parize G, Luana Jimenez G, Shibli JA, Siroma R, Caetano MW, Kim YJ, Braz-Silva PH, da Silva Martinho H, Pallos D. Evaluation of Peri-Implantitis through Fourier-Transform Infrared Spectroscopy on Saliva. J Proteome Res. 2025 Feb 7;24(2):639-648. doi: 10.1021/acs.jproteome.4c00707. Epub 2025 Jan 10.

  PMID: 39792796 BACKGROUND

• Mayer Y, Shibli JA, Saada HA, Melo M, Gabay E, Barak S, Ginesin O. Pulsed Electromagnetic Therapy: Literature Review and Current Update. Braz Dent J. 2024 Oct 25;35:e246109. doi: 10.1590/0103-6440202406109. eCollection 2024.

  PMID: 39476109 BACKGROUND

• Mayer Y, Khoury J, Horwitz J, Ginesin O, Canullo L, Gabay E, Giladi HZ. A novel nonsurgical therapy for peri-implantitis using focused pulsed electromagnetic field: A pilot randomized double-blind controlled clinical trial. Bioelectromagnetics. 2023 Oct-Dec;44(7-8):144-155. doi: 10.1002/bem.22481. Epub 2023 Sep 1.

  PMID: 37655846 BACKGROUND

• 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

Communicable Diseases; Peri-Implantitis; Mucositis

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Jamil A Shibli, PhD

  Guarulhos University

  PRINCIPAL INVESTIGATOR

• Cinthya Massari, DDS

  Guarulhos University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization and placebo MED (medical device not activated or activated for the PEMF)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Control group (healing cap without PEMF); test group with PEMF Comparison with teeth x implants (with or without PEMF)

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: July 1, 2025
• Study Start: May 11, 2025
• Primary Completion: May 11, 2025
• Study Completion: May 11, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)