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

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ClinicalTrials.gov Identifier: NCT03047291
Recruitment Status : Unknown
Verified May 2017 by MARTA GALOFRÉ MERCADÉ, Universitat Internacional de Catalunya.
Recruitment status was:  Active, not recruiting
First Posted : February 8, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
MARTA GALOFRÉ MERCADÉ, Universitat Internacional de Catalunya

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.

Condition or disease Intervention/treatment Phase
Mucositis Peri-implantitis Drug: Probiotic Device: Placebo Oral Tablet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled, parallel design, triple-blind prospective clinical study with a follow-up of 3 months.
Masking: Triple (Participant, Investigator, Outcomes 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).
Primary Purpose: Treatment
Official Title: Clinical and Microbiological Evaluation of the Effect of Probiotic Lactobacillus Reuteri Prodentis in the Treatment of Mucositis and Periimplantitis
Study Start Date : January 1, 2014
Actual Primary Completion Date : March 1, 2017
Estimated Study Completion Date : September 1, 2017

Arm Intervention/treatment
Placebo Comparator: Control group: placebo oral tablet
Placebo tablets. Intervention: 30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
Device: Placebo Oral Tablet
30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.

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




Primary Outcome Measures :
  1. Probing pocket depth [ Time Frame: Differences between baseline and 30 and 90 days will be calculated. ]
    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 :
  1. Plaque index [ Time Frame: Differences between baseline and 30 and 90 days will be calculated. ]
    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.

  2. Bleeding on probing [ Time Frame: Differences between baseline and 30 and 90 days will be calculated. ]
    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.

  3. Microbiological tests [ Time Frame: Differences between baseline and 30 and 90 days will be calculated. ]
    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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047291


Sponsors and Collaborators
Universitat Internacional de Catalunya
Investigators
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Principal Investigator: Marta Galofré Mercadé Universitat Internacional de Catalunya

Publications of Results:
Other Publications:
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Responsible Party: MARTA GALOFRÉ MERCADÉ, DDS, MS, Associated Professor, Universitat Internacional de Catalunya
ClinicalTrials.gov Identifier: NCT03047291     History of Changes
Other Study ID Numbers: Universitat Internacional
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MARTA GALOFRÉ MERCADÉ, Universitat Internacional de Catalunya:
mucositis, periimplantitis, probiotic
Additional relevant MeSH terms:
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Mucositis
Peri-Implantitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases