Use of Probiotics in Oral Health of Patients With Dental Implants

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

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.

Study Overview

• Status: Completed
• Conditions: Mucositis
• Intervention / Treatment: Dietary supplement: Placebo tablets; Dietary supplement: Probiotic tablets of Lactobacillus reuteri

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 Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Department of Oral Surgery, University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Lactobacillus reuteri Vs Placebo; 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: Placebo tablets; Other Names: Placebo tablets with same visually aspect, flavour and texture than the probiotic but without probiotic strains; Dietary supplement: Probiotic tablets of Lactobacillus reuteri; Other Names: strains of Lactobacillus reuteri ATCC PTA 5289 - 100 million; Strains of Lactobacillus reuteri DSM 17938 - 100 million

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of reduction of Total Bacterial Load studied	Where evaluate Aggregatibacter and red complex of socransky	28 days using probiotic tablets/day

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 27, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 27, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Dental implants; Probiotics; Cytokines; Lactobacillus reuteri; Bacterial load; Periimplant mucositis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: Probiotics