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Use of Probiotics in Oral Health of Patients With Dental Implants

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ClinicalTrials.gov Identifier: NCT01974596
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Antonio Juan Flichy Fernández, 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.

Condition or disease Intervention/treatment Phase
Mucositis Dietary Supplement: Probiotic tablets of Lactobacillus reuteri Dietary Supplement: Placebo tablets Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: THE EFFECT OF ORALLY ADMINISTERED PROBIOTIC LACTOBACILLUS REUTERI-CONTAINING TABLETS IN PERI-IMPLANT MUCOSITIS: A RANDOMIZED CLINICAL TRIAL
Study Start Date : January 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


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: Probiotic tablets of Lactobacillus reuteri
Other Names:
  • strains of Lactobacillus reuteri ATCC PTA 5289 - 100 million
  • Strains of Lactobacillus reuteri DSM 17938 - 100 million

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974596


Locations
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Spain
Department of Oral Surgery, University of Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
University of Valencia

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Responsible Party: Antonio Juan Flichy Fernández, DDS, Colaborator University of Valencia, University of Valencia
ClinicalTrials.gov Identifier: NCT01974596     History of Changes
Other Study ID Numbers: Probiotics
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by Antonio Juan Flichy Fernández, University of Valencia:
Dental implants
Probiotics
Lactobacillus reuteri
Periimplant mucositis
Cytokines
Bacterial load

Additional relevant MeSH terms:
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Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases