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Completed

NCT Number: NCT07045636

Microbiome Modulation by PEMF on Plaque Induced Mucositis in Human Jaws

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guarulhos University

Guarulhos, São Paulo, 073040, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

PEMF abd Sham (control)

Other

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

Teeth wih gingivits

Diagnostic Test

Comparison with dental implants

Primary outcomes

  1. Number of clusters of microorganism

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

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

Secondary outcomes

  1. Increase on the soft tissue volume using IOS

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

    Overlapping images according to each period

Sponsors and collaborators

Lead sponsor

Jamil awad shibli

Other

Collaborators

  • Harvard School of Dental Medicine
  • Hospital Israelita Albert Einstein

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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