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Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status

Unknown status

Phase

Phase 2

Locations

Chile

Study Type

Interventional

Intervention

Lactobacillus rhamnosus SP1

Azithromycin

Talc powder

Periodontal treatment Scaling and root planning

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring periodontitis, azithromycin, probiotic

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

14 natural teeth, excluding third molars
10 posterior teeth
35 years old
5 teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm Bleeding on probing ≥20% of sites Extensive bone loss determined radiographically

Exclusion Criteria:

Periodontal treatment before the time of examination
Systemic illness
Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Sites / Locations

Faculty of Dentistry of University of Chile

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Periodontal treatment, talc powder tab

Periodontal treatment, Probitic

Periodontal treatment, Antibiotic

Arm Description

Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months

Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.

Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin

Outcomes

Primary Outcome Measures

Differences of at least 1mm between groups for clinical attachment level changes

Secondary Outcome Measures

Differences between groups for probing depth changes

Differences between groups for bleeding on probing changes

Differences between groups for plaque index changes

Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid

Differences between groups for levels of periodontal pathogens changes

Full Information

NCT ID

NCT02839408

First Posted

July 18, 2016

Last Updated

September 25, 2016

Sponsor

University of Chile

1. Study Identification

Unique Protocol Identification Number

NCT02839408

Brief Title

Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis

Official Title

Efficacy of Oral Probiotic and Antibiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Chile

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP). Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

periodontitis, azithromycin, probiotic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Periodontal treatment, talc powder tab

Arm Type

Placebo Comparator

Arm Description

Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months

Arm Title

Periodontal treatment, Probitic

Arm Type

Experimental

Arm Description

Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.

Arm Title

Periodontal treatment, Antibiotic

Arm Type

Experimental

Arm Description

Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus rhamnosus SP1

Intervention Description

Sachet containing Lactobacillus rhamnosus SP1

Intervention Type

Drug

Intervention Name(s)

Azithromycin

Intervention Description

Tablet containing 500mg Azithromicyn

Intervention Type

Other

Intervention Name(s)

Talc powder

Intervention Description

Sachet containing talc powder and tablet containing talc powder

Intervention Type

Procedure

Intervention Name(s)

Periodontal treatment Scaling and root planning

Primary Outcome Measure Information:

Title

Differences of at least 1mm between groups for clinical attachment level changes

Time Frame