Clinical trial NCT01974596: Use of Probiotics in Oral Health of Patients With Dental Implants
Official title: THE EFFECT OF ORALLY ADMINISTERED PROBIOTIC LACTOBACILLUS REUTERI-CONTAINING TABLETS IN PERI-IMPLANT MUCOSITIS: A RANDOMIZED CLINICAL TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucositis
Keywords: Dental implants
Probiotics
Lactobacillus reuteri
Periimplant mucositis
Cytokines
Bacterial load
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence in reduction of plaque index
timeFrame: 28 days using one probiotic tablet/day
Secondary outcomes:
measure: Evidence in reduction of bleeding around implants
timeFrame: 28 days using probiotic tablet/day
measure: Evidence in reduction of probing depth
timeFrame: 28 days using one probiotic tablet/day
measure: Evidence in reduction Interleukin 1β concentration
timeFrame: 28 days using one probiotic tablet/day
measure: Evidence in reduction Interleukin 6 concentration
timeFrame: 28 days using one probiotic tablet/day
measure: Evidence in reduction Interleukin 8 concentration
timeFrame: 28 days using one probiotic tablet/day
Other outcomes:
measure: Evidence of reduction of Total Bacterial Load studied
timeFrame: 28 days using probiotic tablets/day
Locations:
city: Valencia
country: Spain
facility: Department of Oral Surgery, University of Valencia
Study officials:
References: