Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harvard School of Dental Medicine | OTHER |
| Hospital Israelita Albert Einstein | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Dental implants x teeth | No Intervention | Comparison between tooth and implants (with and without PEMF) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEMF abd Sham (control) | Other | Dental implants receive MED that could (test) or could not (control/SHAM) be activated to emit PEMF |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Increase on the soft tissue volume using IOS | Overlapping images according to each period | time points 0, 3, 6, 7, 14, 21, 28, 42, and 60 days |
Not provided
Inclusion Criteria: -healthy individuals over 18 years of age
Exclusion Criteria: - Individuals with extensive dental restorations;
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jamil A Shibli, PhD | Guarulhos University | Principal Investigator |
| Cinthya Massari, DDS | Guarulhos University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guarulhos University | Guarulhos | São Paulo | 073040 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40011461 | Background | 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. | |
| 39792796 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2023 | Jun 22, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2023 | Jun 22, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D057873 | Peri-Implantitis |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Control group (healing cap without PEMF); test group with PEMF Comparison with teeth x implants (with or without PEMF)
Not provided
Not provided
Randomization and placebo MED (medical device not activated or activated for the PEMF)
| Teeth wih gingivits | Diagnostic Test | Comparison with dental implants |
|
| 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. |
| 39476109 | 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. |
| 37655846 | 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. |
| 32993357 | 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. |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |