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Good bacterias in gingival disease

Introduction of probiotics in periodontal therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5hzq77
Enrollment
Unknown
Registered
2018-08-20
Start date
2017-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Halitosis, periodontitis

Interventions

After the determination of the sample size, 60 volunteers, 30 each group, 24 male, and 36 female, aged between 39 and 79 years (average 57.0 ± 10.57y) were recruited. Test group: Periodontal therapy
for 90 days before sleep. 15 days of Washout
Other
E06.721.189.350
G07.203.300.456.500

Sponsors

Universidade Estadual do Rio de Janeiro
Lead Sponsor
Rit Odontologia
Collaborator
Universidade Estadual do Rio de Janeiro
Collaborator

Eligibility

Age
21 Years to 90 Years

Inclusion criteria

Inclusion criteria: The participants according to the inclusion criteria were patients with chronic periodontitis with at least 20 teeth and Probing Pocket Depth (PPD) 5 mm in at least 6 sites

Exclusion criteria

Exclusion criteria: Without systemic diasease; no periodontal treatment in the last 24 months; without the use of antibiotics in the last 6 months; without pregnancy; without orthodontic therapy; non-smokers; no cardiac pacemaker users

Design outcomes

Primary

MeasureTime frame
Presentation of expected outcome: association of Lactobacillus in the efficacy of adjuvant treatment of chronic periodontitis. Presentation of the method used to verify the expected outcome: Evaluation through periodontal examination and treatment. Also a Tanita device (TTS) and an organoleptic method (OLS) were used to evaluate halitosis. The most important method is the periodontal evaluation of gingival catheterization of patients. Presentation of the parameters (numbers, percentages, indexes, etc.) used to verify if the outcome actually occurred: The sample size was determined based on the study by Mayanagi et al. (2009) and Laleman et al. (2015). Sample size was calculated for the primary endpoint, change in depth of probing (PPD), with an expected difference, it was estimated how many patients were required in each group to provide 80% power and a significance of 95%. Taking into consideration studies comparing the adjuvant effect of probiotics, it was decided to include 30 patients in each group.;Primary outcomes after completion: Clinical improvement of a combination of Lactobacillus in the efficacy of treatment of periodontitis and halitosis, verified by means of periodontal evaluation and halimeter, from the observation of at least 50% in the pre- and post-intervention measurements.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactLéo Soares

Universidade Estadual do Rio de Janeiro

dr_leog@hotmail.com55-24-988189470

Outcome results

None listed

Source: REBEC (via WHO ICTRP)