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Non Surgical Therapy of Periodontitis in Diabetes Patients: the Adjunctive Use of Probiotics

NCT04069611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-01

No results posted yet for this study

Summary

The aim of this study is to evaluate the clinical and microbiological performance of a probiotic formulation (Sunstar GUM Periobalance) as adjunctive to non-surgical periodontal therapy in patients with diabetes. The null hypothesis is that the adjunctive use of this probiotic formulation would not have any additional benefit over scaling and root planning in the number of residual pockets or in the microbiological impact of the treatment. Conversely, the alternative hypothesis is that the adjunctive use of this formulation would improve the clinical results of non-surgical periodontal therapy when compared to scaling and root planing alone, through a modification of the subgingival biofilm composition.

Conditions

Interventions

OTHER

Probiotic

Subjects in the test group will take two probiotic lozenges per day for 3 months (one in the morning and one in the afternoon after brushing their teeth), starting after the last session of SRP. Lozenges will contain L. reuteri (2 x 108 colony forming units/tablet of strains ATCC 55730 and ATCC PTA 5289; Sunstar GUM Periobalance).

OTHER

Placebo

Subjects assigned to the placebo group will take lozenges exactly like the test ones but without bacteria.

PROCEDURE

Scaling and root planing

Mechanical debridement with US and curettes of hard and soft plaque deposits

Sponsors & Collaborators

  • Sunstar, Inc.

    collaborator INDUSTRY

  • Universidad Complutense de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-30
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04069611 on ClinicalTrials.gov