Microbiome Modulation by PEMF on Plaque Induced Mucositis in Human Jaws

Jamil awad shibli

Status: Completed

Conditions: Microbial Colonization; Peri-Implantitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07045636

PEMF and mucositis

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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35 participants in 2 patient groups

PEMF x Control (without PEMF)

Experimental group

Description:

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

Treatment:

Diagnostic Test: Teeth wih gingivits

Other: PEMF abd Sham (control)

Dental implants x teeth

No Intervention group

Description:

Comparison between tooth and implants (with and without PEMF)