Probiotics as Adjunct to Nonsurgical Periodontal Treatment

Periodontitis Clinical Trial

Official title:

Probiotics as Adjunct to Nonsurgical Periodontal Treatment, Double Blinded Randomized Controled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137419
• Other study ID #: 2019-2-1
• Status: Completed
• Phase: N/A
• Start date: November 11, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: April 2020
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ProlacSan probiotic lozenges and gels contain L. plantarum and L. brevis strains with proven in vitro antimicrobial activity against P. gingivalis. In our study we aim to investigate proposed benefit of ProlacSan as adjunct to conventional initial periodontal treatment in a group (n = 40) of Grade III and IV periodontitis patients. Patients will be randomized in two groups receiving either probiotic (n = 20) or placebo (n = 20) after completion of nonsurgical treatment within 7 days. Before treatment and after three months, standard periodontal parameters will be measured by masked examiner and plaque samples harvested for cultivation of 9 most relevant periodontal pathogens. One lozenge per day of probiotic/placebo will be used during 3 months healing period. Primary outcome measures will be the number of persisting sites per patient that need additional surgical treatment defined as sites with probing depth > 4 mm and bleeding on probing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• periodontitis stage III or IV

• at least 20 teeth for evaluation

• besides solitary crowns, no other prosthodontic tooth replacements

• good systemic health

• smoking less than 10 cig/day

Exclusion Criteria:

• periodontal treatment lass than 1 year before inclusion

• antibiotic therapy in the last 6 months

• chronic systemic diseases with the impact on periodontium or healing process

• medication with the impact on periodontium or healing process

Related Conditions & MeSH terms

• Periodontitis

Intervention

Dietary Supplement:
• Probiotic lozenges
Probiotic strains

Other:
• Placebo
Similar to ProlacSan lozenges in taste in colour

Locations

Country	Name	City	State
Slovenia	University Dental Clinic	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual diseased site number	No of sites with probing pocket depth (PPD) > 4 mm and bleeding on probing after treatment	3 months
Primary	Gingival bleeding index	Percentage od bleeding sites after gentle probing of gingival sulcus	3 months
Secondary	Probing pocket depth reduction	Change in probing pocket depth	3 months
Secondary	Recession	Change of the position of the gingival margin	3 months
Secondary	Bleeding on probing	Bleeding after measurement of pocket depth	3 months