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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

Tracking Information
First Submitted Date  ICMJE October 15, 2013
First Posted Date  ICMJE November 1, 2013
Last Update Posted Date November 1, 2013
Study Start Date  ICMJE January 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2013)
  • 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
  • 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.
  • Evidence in reduction Interleukin 1β concentration [ Time Frame: 28 days using one probiotic tablet/day ]
    concentration measured in picograms/milliliter (pg/ml)
  • Evidence in reduction Interleukin 6 concentration [ Time Frame: 28 days using one probiotic tablet/day ]
    concentration measured in picograms/milliliter (pg/ml)
  • Evidence in reduction Interleukin 8 concentration [ Time Frame: 28 days using one probiotic tablet/day ]
    concentration measured in picograms/milliliter (pg/ml)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 27, 2013)
Evidence of reduction of Total Bacterial Load studied [ Time Frame: 28 days using probiotic tablets/day ]
Where evaluate Aggregatibacter and red complex of socransky
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Use of Probiotics in Oral Health of Patients With Dental Implants
Official Title  ICMJE THE EFFECT OF ORALLY ADMINISTERED PROBIOTIC LACTOBACILLUS REUTERI-CONTAINING TABLETS IN PERI-IMPLANT MUCOSITIS: A RANDOMIZED CLINICAL TRIAL
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mucositis
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Interventions:
  • Dietary Supplement: Probiotic tablets of Lactobacillus reuteri
  • Dietary Supplement: Placebo tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2013)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01974596
Other Study ID Numbers  ICMJE Probiotics
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antonio Juan Flichy Fernández, University of Valencia
Study Sponsor  ICMJE University of Valencia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Valencia
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP