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

NCT03047291 | Completed Phase 4 DMC

• 1 other identifier: Universitat Internacional
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mucositis; Peri-implantitis

Keywords

mucositis, periimplantitis, probiotic

Outcome Measures

Primary Outcomes (1)

• 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.

  Differences between baseline and 30 and 90 days will be calculated.

Secondary Outcomes (3)

• Plaque index

  Differences between baseline and 30 and 90 days will be calculated.

• Bleeding on probing

  Differences between baseline and 30 and 90 days will be calculated.

• Microbiological tests

  Differences between baseline and 30 and 90 days will be calculated.

Study Arms (2)

Control group: placebo oral tablet

PLACEBO COMPARATOR

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

Device: Placebo Oral Tablet

Test group: probiotic oral tablet

EXPERIMENTAL

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

Drug: Probiotic

Interventions

Probiotic DRUG

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

Test group: probiotic oral tablet

Placebo Oral Tablet DEVICE

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

Control group: placebo oral tablet

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Related Publications (4)

• 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.

  PMID: 21523225 BACKGROUND

• 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.

  PMID: 25712760 BACKGROUND

• 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.

  PMID: 25953193 BACKGROUND

• 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.

  PMID: 23176716 RESULT

MeSH Terms

Conditions

Mucositis; Peri-Implantitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marta Galofré Mercadé

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients, the clinical examiner, the laboratory technician and the statistician did not know the content of the containers (probiotic or placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MS, Associated Professor

Model Details: A randomized controlled, parallel design, triple-blind prospective clinical study with a follow-up of 3 months.

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: February 8, 2017
• Study Start: January 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share