Mucositis
Conditions
Keywords
Dental implants, Probiotics, Lactobacillus reuteri, Periimplant mucositis, Cytokines, Bacterial load
Brief summary
The aim of this study was evaluate the effects of the oral probiotic Lactobacillus reuteri Prodentis upon the peri-implant health of edentulous patients with dental implants and peri-implant mucositis, establishing comparisons versus implants without peri-implant disease. The hypothesis of the study is that using these probiotics are going to improve the periimplant health.
Detailed description
A double-blind, placebo-controlled, prospective cross-over study was made. All the patients were edentulous and were divided into two groups: A) with no peri-implant disease; B) with peri-implant mucositis affecting one or more implants. Patients with peri-implantitis were excluded. All patients in both groups initially received the oral probiotic Lactobacillus reuteri Prodentis, followed by placebo. Only the supervisor of the study knew this information; clinical examiner and patients were blind. Were studied: crevicular fluid volume, modified plaque index, probing depth, modified gingival index, and concentrations of interleukin 1β, interleukin 6 and interleukin 8, and Bacterial load.
Interventions
DIETARY_SUPPLEMENTProbiotic tablets of Lactobacillus reuteri
DIETARY_SUPPLEMENTPlacebo tablets
Sponsors
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Totally edentulous patients subjected to dental implant rehabilitation in one or both arches * Prosthetic restoration in function for at least 24 months * Healthy individuals without known disease
Exclusion criteria
* Patients receiving any kind of local or systemic decontamination treatment of the oral cavity (e.g., antibiotics or rinses) in the last 3 months, or periodontal treatment in the last 6 months * Uncontrolled periodontal disease * Patients with immune deficiencies, diabetes, rheumatoid disease, head and neck radiotherapy, bisphosphonate treatment, chemotherapy or anticoagulation * Patients with dental implants presenting intraoral exposure of the rough portion of any implant * Smokers * Incomplete protocols due to a lack of patient cooperation: a) failure to follow the treatment instructions; b) failure to report to the visit after one month of follow-up * Failure to provide informed consent to participation the study * Patients presenting at least one implant with peri-implantitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence in reduction of plaque index | 28 days using one probiotic tablet/day | The Mombelli clasification was used to evaluate the reduction of bacterial plaque. 0: No bacterial plaque; 1: presence of bacterial plaque but not visually; 2: 1/3 part of the implant with bacterial plaque; 3: 2/3 parts or more of the implant with bacterial plaque |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evidence in reduction of bleeding around implants | 28 days using probiotic tablet/day | The Mombelli classification was used to evaluate the reduction of bleeding around implants: 0: no bleeding; 1: a point of bleeding; 2)a line of bleeding; 3: much bleeding |
| Evidence in reduction of probing depth | 28 days using one probiotic tablet/day | Was measured in reduction of millimeters of the depth of the implant with a millimeter probe. |
| Evidence in reduction Interleukin 6 concentration | 28 days using one probiotic tablet/day | concentration measured in picograms/milliliter (pg/ml) |
| Evidence in reduction Interleukin 8 concentration | 28 days using one probiotic tablet/day | concentration measured in picograms/milliliter (pg/ml) |
| Evidence in reduction Interleukin 1β concentration | 28 days using one probiotic tablet/day | concentration measured in picograms/milliliter (pg/ml) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evidence of reduction of Total Bacterial Load studied | 28 days using probiotic tablets/day | Where evaluate Aggregatibacter and red complex of socransky |
Countries
Spain
Outcome results
None listed