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Use of Probiotics in Oral Health of Patients With Dental Implants

Primary Purpose

Mucositis

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Probiotic tablets of Lactobacillus reuteri
Placebo tablets
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis focused on measuring Dental implants, Probiotics, Lactobacillus reuteri, Periimplant mucositis, Cytokines, Bacterial load

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Oral Surgery, University of Valencia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Probiotic Lactobacillus reuteri Vs Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Evidence in reduction of plaque index
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

Evidence in reduction of bleeding around implants
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
Was measured in reduction of millimeters of the depth of the implant with a millimeter probe.
Evidence in reduction Interleukin 1β concentration
concentration measured in picograms/milliliter (pg/ml)
Evidence in reduction Interleukin 6 concentration
concentration measured in picograms/milliliter (pg/ml)
Evidence in reduction Interleukin 8 concentration
concentration measured in picograms/milliliter (pg/ml)

Full Information

First Posted
October 15, 2013
Last Updated
October 27, 2013
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT01974596
Brief Title
Use of Probiotics in Oral Health of Patients With Dental Implants
Official Title
THE EFFECT OF ORALLY ADMINISTERED PROBIOTIC LACTOBACILLUS REUTERI-CONTAINING TABLETS IN PERI-IMPLANT MUCOSITIS: A RANDOMIZED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis
Keywords
Dental implants, Probiotics, Lactobacillus reuteri, Periimplant mucositis, Cytokines, Bacterial load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic Lactobacillus reuteri Vs Placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic tablets of Lactobacillus reuteri
Other Intervention Name(s)
strains of Lactobacillus reuteri ATCC PTA 5289 - 100 million, Strains of Lactobacillus reuteri DSM 17938 - 100 million
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablets
Other Intervention Name(s)
Placebo tablets with same visually aspect, flavour and texture than the probiotic but without probiotic strains
Primary Outcome Measure Information:
Title
Evidence in reduction of plaque index
Description
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
Time Frame
28 days using one probiotic tablet/day
Secondary Outcome Measure Information:
Title
Evidence in reduction of bleeding around implants
Description
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
Time Frame
28 days using probiotic tablet/day
Title
Evidence in reduction of probing depth
Description
Was measured in reduction of millimeters of the depth of the implant with a millimeter probe.
Time Frame
28 days using one probiotic tablet/day
Title
Evidence in reduction Interleukin 1β concentration
Description
concentration measured in picograms/milliliter (pg/ml)
Time Frame
28 days using one probiotic tablet/day
Title
Evidence in reduction Interleukin 6 concentration
Description
concentration measured in picograms/milliliter (pg/ml)
Time Frame
28 days using one probiotic tablet/day
Title
Evidence in reduction Interleukin 8 concentration
Description
concentration measured in picograms/milliliter (pg/ml)
Time Frame
28 days using one probiotic tablet/day
Other Pre-specified Outcome Measures:
Title
Evidence of reduction of Total Bacterial Load studied
Description
Where evaluate Aggregatibacter and red complex of socransky
Time Frame
28 days using probiotic tablets/day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Oral Surgery, University of Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

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Use of Probiotics in Oral Health of Patients With Dental Implants

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