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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
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
July 18, 2016
Last Updated
September 25, 2016
Sponsor
University of Chile
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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
baseline, 3, 6, 9 and 12 month
Secondary Outcome Measure Information:
Title
Differences between groups for probing depth changes
Time Frame
baseline, 3, 6, 9 and 12 month
Title
Differences between groups for bleeding on probing changes
Time Frame
baseline, 3, 6, 9 and 12 month
Title
Differences between groups for plaque index changes
Time Frame
baseline, 3, 6, 9 and 12 month
Title
Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid
Time Frame
baseline, 3, 6, 9 and 12 month
Title
Differences between groups for levels of periodontal pathogens changes
Time Frame
baseline, 3, 6, 9 and 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Dentistry of University of Chile
City
Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33413320
Citation
Morales A, Contador R, Bravo J, Carvajal P, Silva N, Strauss FJ, Gamonal J. Clinical effects of probiotic or azithromycin as an adjunct to scaling and root planning in the treatment of stage III periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2021 Jan 7;21(1):12. doi: 10.1186/s12903-020-01276-3.
Results Reference
derived

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

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