Use of Probiotics in Oral Health of Patients With Dental Implants

Phase 2

Completed

• Conditions: Mucositis
• Interventions: Dietary Supplement: Probiotic tablets of Lactobacillus reuteri; Dietary Supplement: Placebo tablets

• Registration Number: NCT01974596
• Lead Sponsor: University of Valencia

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-06
• Study Completion: 2010-07
• Status Verified: 2013-10
• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-27
• Last Update Submitted: 2013-10-27
• Study First Posted: 2013-11-01
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotic Lactobacillus reuteri Vs Placebo	Probiotic tablets of Lactobacillus reuteri	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
Probiotic Lactobacillus reuteri Vs Placebo	Placebo tablets	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 1β concentration	28 days using one probiotic tablet/day	concentration measured in picograms/milliliter (pg/ml)
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)

Trial Locations

Locations (1)

Department of Oral Surgery, University of Valencia; 🇪🇸 Valencia, Spain