Study of Colonization of Strains L.Plantarum and L.Brevis in the Product AB-DENTALAC Chewing Gum

NCT03540498 | Completed

• 1 other identifier: AB-GUM-2016
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study will follow a randomized, double-blind, placebo-controlled design with two groups in parallel,N of 40 patients in 6 weeks of follow up for the evaluation of two different posology models (daily consumption of probiotic gum, with or without previous professional oral cleaning). Probiotics have recently been used to combat oral diseases (plaque control, caries, halitosis, etc.), as a non-invasive natural therapy.

Conditions

Periodontal Disease

Keywords

Oral health; Probiotics; L. plantarum; L. brevis; Periodontics; Dental plaque

Outcome Measures

Primary Outcomes (1)

• Probiotic colonization of the oral cavity (qPCR)

  Quantification of L. brevis and L. plantarum by species-specific qPCR in pooled samples of saliva, dental plaque (from the CPI subset) and lingual plaque

  Change from Baseline assessed 6 weeks after study entry

Secondary Outcomes (2)

• Progression of PII

  Change from Baseline assessed 6 weeks after study entry

• Progression of GI

  Change from Baseline assessed 6 weeks after study entry

Study Arms (2)

Probiotics

EXPERIMENTAL

The volunteers will follow the assigned treatment for 6 weeks (PROBIOTICS\_AB-DENTALAC CHEWING GUM. Orally) , which will consist of the consumption of 2 chewing gums a day. The chewing gum should be chewed for at least 15-20 minutes at least 1 hour after the consumption of food. For at least 1 hour after the consumption of chewing gum, volunteers will not be able to consume food, drink (except water) or clean their teeth. Adherence to the treatment will be made by returning the empty containers after 6 weeks.

Dietary Supplement: AB-DENTALAC [Probiotics (study)]

Control

PLACEBO COMPARATOR

The volunteers will follow the assigned treatment for 6 weeks (PLACEBOS CHEWING GUM. Orally) , which will consist of the consumption of 2 chewing gums a day. The chewing gum should be chewed for at least 15-20 minutes at least 1 hour after the consumption of food. For at least 1 hour after the consumption of chewing gum, volunteers will not be able to consume food, drink (except water) or clean their teeth. Adherence to the treatment will be made by returning the empty containers.

Dietary Supplement: Placebo (control)

Interventions

AB-DENTALAC [Probiotics (study)] DIETARY_SUPPLEMENT

Treatment for 6 weeks, which will consist of the consumption of a chewing gum AB-DENTALAC with 100mg L.plantarum + L.brevis Probiotics blend (5E+8 CFU each at the end of shelf life), b.i.d (morning and evening).

Probiotics

Placebo (control) DIETARY_SUPPLEMENT

Treatment for 6 weeks, which will consist of the consumption of a chewing gum placebo, without probiotics strains, b.i.d (morning and evening).

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women and men between 18-55 years.
• Capacity to understand the procedures and implications of the study.
• Gingival Index \<1,5 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51)
• Plaque Index \<2,0 (Löe and Silness, Acta Odontol Scand. 1963. 21:533-51)
• Periodontal pocket depth \<5 mm

You may not qualify if:

• Less than 20 natural teeth
• More than 2 untreated caries at the time of enrollment
• Current orthodontic or periodontal treatment
• Hypersensitivity or allergy to any of the ingredients of the experimental product
• Consumption of antibiotics in the 8 weeks prior to treatment
• Use of probiotics designed to improve oral health, or having consumed them during the 8 weeks prior to the study
• Consumption of any type of probiotic during the 4 weeks prior to the study
• Usual consumption of clorhexidine or other mouthwashes with bactericidal active ingredients during the 30 days before the start of the study
• Pregnant or lactating women
• Participants with chronic diseases (eg, diabetes, kidney problems, cancer) or under chronic treatment

Sponsors & Collaborators

• AB Biotics, SA: lead
• Clínica Odontológica Nart en Barcelona: collaborator

Related Publications (1)

• Nart J, Jimenez-Garrido S, Ramirez-Sebastia A, Asto E, Buj D, Huedo P, Espadaler J. Oral colonization by Levilactobacillus brevis KABPTM-052 and Lactiplantibacillus plantarum KABPTM-051: A Randomized, Double-Blinded, Placebo-Controlled Trial (Pilot Study). J Clin Exp Dent. 2021 May 1;13(5):e433-e439. doi: 10.4317/jced.57771. eCollection 2021 May.

  PMID: 33981389 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Dental Plaque

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jordi Espadaler Mazo, PhD

  AB Biotics, SA

  STUDY CHAIR

• Jose Nart Molina, DMD

  Clínica Odontológica Nart en Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Once the patients have been selected according to the inclusion / exclusion criteria detailed below, they will be included in one of the treatment groups (control / study) in a random and random manner. The list of randomization and the labeling of the products will be carried out by independent personnel to the research team to ensure double blindness of the trial. The production of the probiotic products and control will be carried out in both cases in white boxes without any type of identification or difference between them. The randomization will be made from an online software available at www.randomization.com. From the list of randomization generated by this software, the different products will be labeled with the patient number and the test code. The team of researchers will not have access to the randomization list. In this way, a correct randomization and double-blind trial is guaranteed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will follow a randomized, double-blind, split-mouth, placebo-controlled design with two parallel prospective follow-up groups for the evaluation of two different posology models (with or without previous professional oral cleaning).

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 30, 2018
• Study Start: October 13, 2016
• Primary Completion: November 24, 2016
• Study Completion: February 27, 2017
• Last Updated: December 18, 2019

Record last verified: 2019-12