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MucositisPhase 2NCT01974596

Use of Probiotics in Oral Health of Patients With Dental Implants

A Phase 2 study testing Probiotic tablets of Lactobacillus reuteri in people with Mucositis, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Mucositis
What is being tested?
Probiotic tablets of Lactobacillus reuteri
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteSpain
Study dates
Jan 2008to Jul 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Department of Oral Surgery, University of Valencia

    Valencia, Valencia, 46010

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
Mucositis
Being tested
Probiotic tablets of Lactobacillus reuteri, Placebo tablets
Keywords
Dental implants, Probiotics, Lactobacillus reuteri, Periimplant mucositis, Cytokines, Bacterial load
Medical subject headings
Mucositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic tablets of Lactobacillus reuteriDietary supplement

    Also called strains of Lactobacillus reuteri ATCC PTA 5289 - 100 million, Strains of Lactobacillus reuteri DSM 17938 - 100 million

  • Placebo tabletsDietary supplement

    Also called Placebo tablets with same visually aspect, flavour and texture than the probiotic but without probiotic strains

Study groups in NCT01974596
Study groupRoleWhat they receive
Probiotic Lactobacillus reuteri Vs PlaceboExperimentalpatients 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
Receives: Dietary Supplement: Probiotic tablets of Lactobacillus reuteri; Dietary Supplement: Placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 28 days using one probiotic tablet/day

Secondary outcomes (5)

  1. 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

    Measured: 28 days using probiotic tablet/day

  2. Evidence in reduction of probing depth

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

    Measured: 28 days using one probiotic tablet/day

  3. Evidence in reduction Interleukin 1β concentration

    concentration measured in picograms/milliliter (pg/ml)

    Measured: 28 days using one probiotic tablet/day

  4. Evidence in reduction Interleukin 6 concentration

    concentration measured in picograms/milliliter (pg/ml)

    Measured: 28 days using one probiotic tablet/day

  5. Evidence in reduction Interleukin 8 concentration

    concentration measured in picograms/milliliter (pg/ml)

    Measured: 28 days using one probiotic tablet/day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2013 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2008
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01974596
Sponsor's protocol ID
Probiotics
Status last verified
Oct 2013
First submitted
15 Oct 2013
Last updated
1 Nov 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Probiotic tablets of Lactobacillus reuteri in people with Mucositis, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evidence in reduction of plaque index (time frame: 28 days using one probiotic tablet/day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01974596.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.

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