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Effect of Probiotic Lactobacillus Reuteri in the Treatment of Mucositis and Periimplantitis

Primary Purpose

Mucositis, Peri-implantitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Probiotic
Placebo Oral Tablet
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis focused on measuring mucositis, periimplantitis, probiotic

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adult patients with general good health,
  • non-smokers,
  • history of mild or moderate chronic periodontitis
  • at least one dental implant with probing pocket depth ≥4mm together with bleeding on probing and/or suppuration, and a fixed prosthetic restoration in function for at least 12 months,
  • compliance with the periodontal maintenance program,
  • accessibility during all the study period and receptiveness and ability to fulfill with the protocol.

Exclusion Criteria:

  • pregnant or lactating women,
  • patients who required prophylaxis of bacterial endocarditis or had taken local or systemic antibiotic, anti-inflammatory, antiseptic or probiotic therapy in the previous 3 months,
  • subjects who had received surgical periodontal treatment in the last 6 months,
  • uncontrolled periodontal disease,
  • previous or current history of alcoholism or smoking,
  • treatment with bisphosphonates, neurologic deficiencies, systemic diseases such as immunodeficiencies or uncontrolled diabetes, rheumatoid, hepatic, renal, cardiovascular or infectious pathologies, radiotherapy, chemotherapy, use of any medication which can affect at periodontal level,
  • lack of patient cooperation (failure to follow the treatment instructions and/or failure to attend visits),
  • implants with mobility and/or radiographic bone loss ≥ 5mm and/or ≥ 50% of implant length.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Control group: placebo oral tablet

    Test group: probiotic oral tablet

    Arm Description

    Placebo tablets. Intervention: 30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.

    Probiotic tablets (Periobalance®, Sunstar, Switzerland). Intervention: 30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.

    Outcomes

    Primary Outcome Measures

    Probing pocket depth
    The probing pocket depth was recorded, in millimeters and at six points per tooth and implant, as the distance from the gingival margin to the bottom of the periodontal pocket and peri-implant mucosa. Measurements will be performed by a masked and calibrated investigator.

    Secondary Outcome Measures

    Plaque index
    The general plaque index (PI) was recorded according to O'Leary et al., dichotomously assigning the presence or absence of plaque on four surfaces per tooth and implant. The implant plaque index (IPI) was recorded by assigning a dichotomous value to the presence or absence of plaque (1 indicating presence of plaque and 0 absence of plaque) of the implant under study. Measurements will be performed by a masked and calibrated investigator.
    Bleeding on probing
    The general bleeding on probing (BOP) was determined according to Ainamo and Bay, evaluating dichotomously the presence or absence of bleeding on the mesial, distal, buccal and lingual/palatal dental or implant surfaces. The implant bleeding on probing (BOPI) was recorded using a dichotomous value depending on whether the implant under study presented bleeding or not (1 indicated bleeding and 0 no bleeding). Measurements will be performed by a masked and calibrated investigator.
    Microbiological tests
    Microbiological tests were performed in the deepest periimplant pocket, using the Guidor Perio-Implant Diagnostic Test® (Sunstar S.A, Switzerland), which by means of Real-Time PCR identified and quantified the total bacterial load of A. actinomycetemcomitans (DSM 8324), T. forsythia (CIP 105220), P. gingivalis (DSM 20709), T. denticola (DSM 14222), P. intermedia (DSM 20706), P. micros (DSM 20468), F. nucleatum (DSM 20482), C. rectus (LMG 18530) and E. corrodens (DSM 8340). Measurements will be performed by a masked and calibrated investigator.

    Full Information

    First Posted
    January 29, 2017
    Last Updated
    March 27, 2020
    Sponsor
    Universitat Internacional de Catalunya
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03047291
    Brief Title
    Effect of Probiotic Lactobacillus Reuteri in the Treatment of Mucositis and Periimplantitis
    Official Title
    Clinical and Microbiological Evaluation of the Effect of Probiotic Lactobacillus Reuteri Prodentis in the Treatment of Mucositis and Periimplantitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (undefined)
    Primary Completion Date
    March 1, 2017 (Actual)
    Study Completion Date
    September 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universitat Internacional de Catalunya

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Evaluate clinically and microbiologically the effect of the oral probiotic Lactobacillus reuteri Prodentis (PerioBalance®, Sunstar, Switzerland) on implants with mucositis or periimplantitis, as a coadjuvant treatment of mechanical therapy.
    Detailed Description
    A total of 44 patients, 22 with mucositis and 22 with periimplantitis, were randomly assigned to either the control or the test group, so that 11 patients received placebo and 11 probiotic treatment. After the baseline clinical, radiological and microbiological examination, and once the study group was randomly assigned (probiotic or placebo), supragingival prophylaxis was performed in the mucositis group and subgingival mechanical therapy in the periimplantitis group. Then they get a container with 30 probiotic or placebo tablets and instructions on how and when to take them. At 30 and 90 days after beginning the treatment, a clinical, radiological and microbiological examination was performed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mucositis, Peri-implantitis
    Keywords
    mucositis, periimplantitis, probiotic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized controlled, parallel design, triple-blind prospective clinical study with a follow-up of 3 months.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    The patients, the clinical examiner, the laboratory technician and the statistician did not know the content of the containers (probiotic or placebo).
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group: placebo oral tablet
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablets. Intervention: 30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
    Arm Title
    Test group: probiotic oral tablet
    Arm Type
    Experimental
    Arm Description
    Probiotic tablets (Periobalance®, Sunstar, Switzerland). Intervention: 30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
    Intervention Type
    Drug
    Intervention Name(s)
    Probiotic
    Intervention Description
    30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
    Intervention Type
    Device
    Intervention Name(s)
    Placebo Oral Tablet
    Intervention Description
    30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
    Primary Outcome Measure Information:
    Title
    Probing pocket depth
    Description
    The probing pocket depth was recorded, in millimeters and at six points per tooth and implant, as the distance from the gingival margin to the bottom of the periodontal pocket and peri-implant mucosa. Measurements will be performed by a masked and calibrated investigator.
    Time Frame
    Differences between baseline and 30 and 90 days will be calculated.
    Secondary Outcome Measure Information:
    Title
    Plaque index
    Description
    The general plaque index (PI) was recorded according to O'Leary et al., dichotomously assigning the presence or absence of plaque on four surfaces per tooth and implant. The implant plaque index (IPI) was recorded by assigning a dichotomous value to the presence or absence of plaque (1 indicating presence of plaque and 0 absence of plaque) of the implant under study. Measurements will be performed by a masked and calibrated investigator.
    Time Frame
    Differences between baseline and 30 and 90 days will be calculated.
    Title
    Bleeding on probing
    Description
    The general bleeding on probing (BOP) was determined according to Ainamo and Bay, evaluating dichotomously the presence or absence of bleeding on the mesial, distal, buccal and lingual/palatal dental or implant surfaces. The implant bleeding on probing (BOPI) was recorded using a dichotomous value depending on whether the implant under study presented bleeding or not (1 indicated bleeding and 0 no bleeding). Measurements will be performed by a masked and calibrated investigator.
    Time Frame
    Differences between baseline and 30 and 90 days will be calculated.
    Title
    Microbiological tests
    Description
    Microbiological tests were performed in the deepest periimplant pocket, using the Guidor Perio-Implant Diagnostic Test® (Sunstar S.A, Switzerland), which by means of Real-Time PCR identified and quantified the total bacterial load of A. actinomycetemcomitans (DSM 8324), T. forsythia (CIP 105220), P. gingivalis (DSM 20709), T. denticola (DSM 14222), P. intermedia (DSM 20706), P. micros (DSM 20468), F. nucleatum (DSM 20482), C. rectus (LMG 18530) and E. corrodens (DSM 8340). Measurements will be performed by a masked and calibrated investigator.
    Time Frame
    Differences between baseline and 30 and 90 days will be calculated.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: adult patients with general good health, non-smokers, history of mild or moderate chronic periodontitis at least one dental implant with probing pocket depth ≥4mm together with bleeding on probing and/or suppuration, and a fixed prosthetic restoration in function for at least 12 months, compliance with the periodontal maintenance program, accessibility during all the study period and receptiveness and ability to fulfill with the protocol. Exclusion Criteria: pregnant or lactating women, patients who required prophylaxis of bacterial endocarditis or had taken local or systemic antibiotic, anti-inflammatory, antiseptic or probiotic therapy in the previous 3 months, subjects who had received surgical periodontal treatment in the last 6 months, uncontrolled periodontal disease, previous or current history of alcoholism or smoking, treatment with bisphosphonates, neurologic deficiencies, systemic diseases such as immunodeficiencies or uncontrolled diabetes, rheumatoid, hepatic, renal, cardiovascular or infectious pathologies, radiotherapy, chemotherapy, use of any medication which can affect at periodontal level, lack of patient cooperation (failure to follow the treatment instructions and/or failure to attend visits), implants with mobility and/or radiographic bone loss ≥ 5mm and/or ≥ 50% of implant length.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marta Galofré Mercadé
    Organizational Affiliation
    Universitat Internacional de Catalunya
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21523225
    Citation
    Vivekananda MR, Vandana KL, Bhat KG. Effect of the probiotic Lactobacilli reuteri (Prodentis) in the management of periodontal disease: a preliminary randomized clinical trial. J Oral Microbiol. 2010 Nov 2;2. doi: 10.3402/jom.v2i0.5344.
    Results Reference
    background
    PubMed Identifier
    25712760
    Citation
    Flichy-Fernandez AJ, Ata-Ali J, Alegre-Domingo T, Candel-Marti E, Ata-Ali F, Palacio JR, Penarrocha-Diago M. The effect of orally administered probiotic Lactobacillus reuteri-containing tablets in peri-implant mucositis: a double-blind randomized controlled trial. J Periodontal Res. 2015 Dec;50(6):775-85. doi: 10.1111/jre.12264. Epub 2015 Feb 25.
    Results Reference
    background
    PubMed Identifier
    25953193
    Citation
    Hallstrom H, Lindgren S, Widen C, Renvert S, Twetman S. Probiotic supplements and debridement of peri-implant mucositis: a randomized controlled trial. Acta Odontol Scand. 2016;74(1):60-6. doi: 10.3109/00016357.2015.1040065. Epub 2015 May 8.
    Results Reference
    background
    PubMed Identifier
    23176716
    Citation
    Vicario M, Santos A, Violant D, Nart J, Giner L. Clinical changes in periodontal subjects with the probiotic Lactobacillus reuteri Prodentis: a preliminary randomized clinical trial. Acta Odontol Scand. 2013 May-Jul;71(3-4):813-9. doi: 10.3109/00016357.2012.734404. Epub 2012 Nov 26.
    Results Reference
    result

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    Effect of Probiotic Lactobacillus Reuteri in the Treatment of Mucositis and Periimplantitis

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