NCT01974596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

5 months

First QC Date

October 15, 2013

Last Update Submit

October 27, 2013

Conditions

Mucositis

Keywords

Dental implantsProbioticsLactobacillus reuteriPeriimplant mucositisCytokinesBacterial load

Outcome Measures

Primary Outcomes (1)

  • 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

    28 days using one probiotic tablet/day

Secondary Outcomes (5)

  • Evidence in reduction of bleeding around implants

    28 days using probiotic tablet/day

  • Evidence in reduction of probing depth

    28 days using one probiotic tablet/day

  • Evidence in reduction Interleukin 1β concentration

    28 days using one probiotic tablet/day

  • Evidence in reduction Interleukin 6 concentration

    28 days using one probiotic tablet/day

  • Evidence in reduction Interleukin 8 concentration

    28 days using one probiotic tablet/day

Other Outcomes (1)

  • Evidence of reduction of Total Bacterial Load studied

    28 days using probiotic tablets/day

Study Arms (1)

Probiotic Lactobacillus reuteri Vs Placebo

EXPERIMENTAL

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 reuteriDietary Supplement: Placebo tablets

Interventions

Probiotic tablets of Lactobacillus reuteriDIETARY_SUPPLEMENT
Also known as: strains of Lactobacillus reuteri ATCC PTA 5289 - 100 million, Strains of Lactobacillus reuteri DSM 17938 - 100 million
Probiotic Lactobacillus reuteri Vs Placebo
Placebo tabletsDIETARY_SUPPLEMENT
Also known as: Placebo tablets with same visually aspect, flavour and texture than the probiotic but without probiotic strains
Probiotic Lactobacillus reuteri Vs Placebo

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oral Surgery, University of Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Mucositis

Interventions

ProbioticsFlavoring Agents

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPharmaceutic AidsPharmaceutical PreparationsFood AdditivesFood IngredientsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, Colaborator University of Valencia

Study Record Dates

First Submitted

October 15, 2013

First Posted

November 1, 2013

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

July 1, 2010

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

ES(1)