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NCT Number: NCT03047291

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

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.

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Key information

Conditions

Mucositis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Drug

30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.

Placebo Oral Tablet

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

Clinical and Microbiological Evaluation of the Effect of Probiotic Lactobacillus Reuteri Prodentis in the Treatment of Mucositis and Periimplantitis

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 8, 2017
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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