Use of Probiotics in Oral Health of Patients With Dental Implants

NCT ID: NCT01974596

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-07-31

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.

Conditions

Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

Probiotic tablets of Lactobacillus reuteri

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablets

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Probiotic tablets of Lactobacillus reuteri

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablets

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

strains of Lactobacillus reuteri ATCC PTA 5289 - 100 million; Strains of Lactobacillus reuteri DSM 17938 - 100 million; Placebo tablets with same visually aspect, flavour and texture than the probiotic but without probiotic strains

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Antonio Juan Flichy Fernández

DDS, Colaborator University of Valencia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Oral Surgery, University of Valencia

Valencia, Valencia, Spain

Countries

Spain

Other Identifiers

Probiotics

Identifier Type: -

Identifier Source: org_study_id