Clinical trial NCT03047291: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mucositis
Peri-implantitis
Keywords: mucositis, periimplantitis, probiotic
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled, parallel design, triple-blind prospective clinical study with a follow-up of 3 months.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Probing pocket depth
timeFrame: Differences between baseline and 30 and 90 days will be calculated.
Secondary outcomes:
measure: Plaque index
timeFrame: Differences between baseline and 30 and 90 days will be calculated.
measure: Bleeding on probing
timeFrame: Differences between baseline and 30 and 90 days will be calculated.
measure: Microbiological tests
timeFrame: Differences between baseline and 30 and 90 days will be calculated.
Other outcomes:
Locations:
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Marta Galofré Mercadé
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.