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Completed

NCT Number: NCT01974596

Use of Probiotics in Oral Health of Patients With Dental Implants

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.

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Stomatognathic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oral Surgery, University of Valencia

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic tablets of Lactobacillus reuteri

Dietary Supplement

Other names: strains of Lactobacillus reuteri ATCC PTA 5289 - 100 million, Strains of Lactobacillus reuteri DSM 17938 - 100 million

Placebo tablets

Dietary Supplement

Other names: Placebo tablets with same visually aspect, flavour and texture than the probiotic but without probiotic strains

Primary outcomes

  1. Evidence in reduction of plaque index

    Time frame: 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 outcomes

  1. Evidence in reduction of bleeding around implants

    Time frame: 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

  2. Evidence in reduction of probing depth

    Time frame: 28 days using one probiotic tablet/day

    Was measured in reduction of millimeters of the depth of the implant with a millimeter probe.

  3. Evidence in reduction Interleukin 1β concentration

    Time frame: 28 days using one probiotic tablet/day

    concentration measured in picograms/milliliter (pg/ml)

  4. Evidence in reduction Interleukin 6 concentration

    Time frame: 28 days using one probiotic tablet/day

    concentration measured in picograms/milliliter (pg/ml)

  5. Evidence in reduction Interleukin 8 concentration

    Time frame: 28 days using one probiotic tablet/day

    concentration measured in picograms/milliliter (pg/ml)

Other outcomes

  1. Evidence of reduction of Total Bacterial Load studied

    Time frame: 28 days using probiotic tablets/day

    Where evaluate Aggregatibacter and red complex of socransky

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2010
First posted
Nov 1, 2013
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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