MedDataX Logo

Use of Probiotics in Oral Health of Patients With Dental Implants

NCT ID: NCT01974596

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mucositis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dental implants Probiotics Lactobacillus reuteri Periimplant mucositis Cytokines Bacterial load

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Probiotic tablets of Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

Placebo tablets

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Antonio Juan Flichy Fernández

DDS, Colaborator University of Valencia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Oral Surgery, University of Valencia

Valencia, Valencia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Probiotics

Identifier Type: -

Identifier Source: org_study_id