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Microbial ColonizationNCT07045636

Microbiome Modulation by PEMF on Plaque Induced Mucositis in Human Jaws

A study testing Teeth wih gingivits in people with Microbial Colonization and Peri-Implantitis, run by Jamil awad shibli at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Microbial Colonization, Peri-Implantitis
What is being tested?
Teeth wih gingivits
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35 participants
Where
1 siteBrazil
Study dates
11 May 2025to 11 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Inclusion Criteria: -healthy individuals over 18 years of age

  • 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

Exclusion Criteria: - Individuals with extensive dental restorations;

  • 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 .

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Guarulhos University

    Guarulhos, São Paulo, 073040

Other trials in Brazil

About this study

Official title: Microbial Modulation by PEMF on Paque Induced Mucositis in Dental Implants Placed in Human Jaws: Microbiome and Proteomic Analysis.

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).

Read the detailed description

As in natural teeth, bacterial colonization of the implant surface can trigger a reversible inflammatory process in the peri-implant soft tissue-defined mucositis. However, differences in the organization of peri-implant tissues may combat the progression of lesions associated with bacterial biofilm, resulting in a broader inflammatory infiltrate compared to periodontal tissues. Some previous studies have used electromagnetic pulses (PEMF-pulse electromagnetic fields) to modulate bacterial biofilm. Thus, the objective of this study will be to evaluate the host response pattern (proteomics, microbiome, and clinical) during the induction and progression of experimental gingivitis and mucositis in humans with the action of the electromagnetic pulse. Forty systemically healthy individuals will be included, who must present the need for two implant-supported restorations adjacent to the teeth. Individuals will receive oral hygiene instruction and professional prophylaxis fortnightly, 30 days before implant installation. The implants will be installed in time -60 days. After 60 days, at baseline, the healing abutment will be installed on the two implants, one conventional and the other with an electromagnetic pulse. At the same time, everyone will receive acetate plates to protect the selected areas (tooth and implants) during brushing, to be used for 21 days. Clinical periodontal parameters, microbiological (supragingival and subgingival biofilm), and immunological (crevicular fluid) collections will be obtained at 0, 3, 7, 14, 21, 42, and 60 days. IOS will be performed in all the periods. The results will be evaluated for normality using the D'Agostino test. Then, parametric or non-parametric tests will be applied to compare the means/medians obtained between the gingivitis and mucositis groups in the different periods of the study.

Being tested
PEMF abd Sham (control), Teeth wih gingivits
Keywords
dental implants, peri-implantitis, mucositis, microbiome, proteomic
Medical subject headings
Communicable Diseases, Peri-Implantitis, Mucositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEMF abd Sham (control)Other

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

  • Teeth wih gingivitsDiagnostic test

    Comparison with dental implants

Study groups in NCT07045636
Study groupRoleWhat they receive
PEMF x Control (without PEMF)ExperimentalTest 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
Receives: Other: PEMF abd Sham (control); Diagnostic Test: Teeth wih gingivits
Dental implants x teethNo interventionComparison between tooth and implants (with and without PEMF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of clusters of microorganism

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

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

Secondary outcomes (1)

  1. Increase on the soft tissue volume using IOS

    Overlapping images according to each period

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2025
  2. Study start11 May 2025
  3. Primary completion11 May 2025
  4. Study completion11 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Control group (healing cap without PEMF); test group with PEMF Comparison with teeth x implants (with or without PEMF)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07045636
Sponsor's protocol ID
PEMF and mucositis
Status last verified
Apr 2026
First submitted
15 May 2025
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40011461

  • 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.

    PubMed 39792796

  • 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.

    PubMed 39476109

  • 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.

    PubMed 37655846

  • 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.

    PubMed 32993357

Questions about this trial

What is this clinical trial studying?

A study testing Teeth wih gingivits in people with Microbial Colonization and Peri-Implantitis, run by Jamil awad shibli at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of clusters of microorganism (time frame: time points 0, 3, 6, 7, 14, 21, 28, 42, and 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07045636, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

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