Microbiome Modulation by PEMF on Plaque Induced Mucositis in Human Jaws

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-11

Study Completion Date

2025-05-11

Brief Summary

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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.

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Detailed Description

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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. 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.

Conditions

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Microbial Colonization Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Randomization and placebo MED (medical device not activated or activated for the PEMF)

Study Groups

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PEMF x Control (without PEMF)

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

Group Type EXPERIMENTAL

PEMF abd Sham (control)

Intervention Type OTHER

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

Teeth wih gingivits

Intervention Type DIAGNOSTIC_TEST

Comparison with dental implants

Dental implants x teeth

Comparison between tooth and implants (with and without PEMF)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PEMF abd Sham (control)

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

Intervention Type OTHER

Teeth wih gingivits

Comparison with dental implants

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

* 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 .

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes