Microbial Colonization, Peri-Implantitis
Conditions
Keywords
dental implants, peri-implantitis, mucositis, microbiome, proteomic
Brief 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. 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).
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.
Interventions
OTHERPEMF abd Sham (control)
Dental implants receive MED that could (test) or could not (control/SHAM) be activated to emit PEMF
DIAGNOSTIC_TESTTeeth wih gingivits
Comparison with dental implants
Sponsors
Jamil awad shibli
Harvard School of Dental Medicine
Hospital Israelita Albert Einstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Randomization and placebo MED (medical device not activated or activated for the PEMF)
Intervention model description
Control group (healing cap without PEMF); test group with PEMF Comparison with teeth x implants (with or without PEMF)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of clusters of microorganism | 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
| Measure | Time frame | Description |
|---|---|---|
| Increase on the soft tissue volume using IOS | time points 0, 3, 6, 7, 14, 21, 28, 42, and 60 days | Overlapping images according to each period |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORJamil A Shibli, PhD
Guarulhos University
STUDY_DIRECTORCinthya Massari, DDS
Guarulhos University
Outcome results
None listed