Use of Probiotics in Oral Health of Patients With Dental Implants

University of Valencia

Status and phase: Completed; Phase 2

Conditions: Mucositis

Treatments: Dietary Supplement: Placebo tablets; Dietary Supplement: Probiotic tablets of Lactobacillus reuteri

Study type: Interventional

Funder types: Other

Identifiers

NCT01974596

Probiotics

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 1 patient group

Probiotic Lactobacillus reuteri Vs Placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic tablets of Lactobacillus reuteri

Dietary Supplement: Placebo tablets