Use of Probiotics in Oral Health of Patients With Dental Implants

Study Overview
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Brief Summary
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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
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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.

Official Title
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THE EFFECT OF ORALLY ADMINISTERED PROBIOTIC LACTOBACILLUS REUTERI-CONTAINING TABLETS IN PERI-IMPLANT MUCOSITIS: A RANDOMIZED CLINICAL TRIAL

Conditions
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Mucositis

Intervention / Treatment
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* Dietary Supplement: Probiotic tablets of Lactobacillus reuteri
* Dietary Supplement: Placebo tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic Lactobacillus reuteri Vs Placebo<br>patients with full arch with dental implant received a tablet of Lactobacillus reuteri every day during 28 days, and after a wash-up, the same patients receive a tablet of placebo every day during 28 days | Dietary Supplement: Probiotic tablets of Lactobacillus reuteri<br> <br> * Other names: Strains of Lactobacillus reuteri DSM 17938 - 100 million;Dietary Supplement: Placebo tablets<br> <br> * Other names: Placebo tablets with same visually aspect, flavour and texture than the probiotic but without probiotic strains;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence in reduction of plaque index | 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 | 28 days using one probiotic tablet/day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence in reduction of bleeding around implants | 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 | 28 days using probiotic tablet/day | 
| Evidence in reduction of probing depth | Was measured in reduction of millimeters of the depth of the implant with a millimeter probe. | 28 days using one probiotic tablet/day | 
| Evidence in reduction Interleukin 1β concentration | concentration measured in picograms/milliliter (pg/ml) | 28 days using one probiotic tablet/day | 
| Evidence in reduction Interleukin 6 concentration | concentration measured in picograms/milliliter (pg/ml) | 28 days using one probiotic tablet/day | 
| Evidence in reduction Interleukin 8 concentration | concentration measured in picograms/milliliter (pg/ml) | 28 days using one probiotic tablet/day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implants, Probiotics, Lactobacillus reuteri, Periimplant mucositis, Cytokines, Bacterial load