NCT04137419

Probiotics as Adjunct to Nonsurgical Periodontal Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Ljubljana · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic lozenges	Probiotic strains
OTHER	Placebo	Similar to ProlacSan lozenges in taste in colour

Timeline

• Start date: 2018-11-11
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2019-10-24
• Last updated: 2020-05-01

Locations

1 site across 1 country: Slovenia